MAUDE Adverse Event Report: ROHO, INC. ROHO QUADTRO SELECT LOW PROFILE CUSHION; WHEELCHAIR CUSHION

Model Number QS910LPC

Device Problems Loss of or Failure to Bond (1068); Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

The fiancé of the end user alleges that he has developed a large pressure injury following the extended use of a deflated cushion.Per the finance, his cushion went flat while the family was travelling, and once he advised them, they were unable to determine why-so a "bed pillow was cut up" and used to raise the deflated area of the cushion until they arrived back home.Reportedly, the end user has a history of receiving pressure injuries, noting that this is his 3rd one.The caller states that the end user has a hard time finding a cushion that works for him properly.It is reported that the end user was hospitalized due to an infection and a fever of 103.3, while also having a pressure injury.The caller is unsure about how long the end user was sitting on the deflated cushion due to the end user being secretive about his self-care.Recently, it was confirmed that the end user is home, and that they have stabilized per physicians.The caller states that the end user has a hard time finding a cushion that works for him properly, and that he feels the immersion function of the current cushion makes him sink in too much.It was suggested that the end user see a seating specialist as soon as possible to ensure that positioning is appropriate.A replacement cushion was sent to the caller and a return label was given so that the cushion of concern could be evaluated.As of 10/18, the cushion has not been received.Per caller, daily hand checks as detailed in the manual, were not being conducted.The end user is replacing his wheelchair and has arranged for a seating specialist to come out to ensure that the chair is a proper fit for him, and then to complete the initial set up of the replacement cushion that was received.Subsequent check-ins with the caller have all returned positive progress notes, and the end user continues to offload throughout the day until consultation with the seating specialist has occurred.Although an alleged injury is reported, no medical documents have been submitted for confirmation.A dhr review is being conducted and information will be added to the physical complaint file.If additional contact is made with the end user or if additional information is obtained, then the information provided will be updated.Initial submission attempt was made on friday, october 21st.However, due to technical difficulties the esg helpdesk was needed.Response from the esg helpdesk occured on monday, october 21st, and so report was submitted.

Event Description

Customer's fiancé called in and stated that their family went on vacation.The cushion allegedly went flat, and the end user didn't say anything initially and continued to use the cushion.Once it was discovered, the fiancé cut up a pillow and placed the pieces under the end user since the back quads of the cushion were not holding air.End user was taken to the hospital upon arriving home.Fiancé stated that end user had a big pressure sore and a 103.3-degree fever.

Manufacturer Narrative

The fiancé of the end user alleges that he has developed a large pressure injury following the extended use of a deflated cushion.Per the finance, his cushion went flat while the family was travelling, and once he advised them, they were unable to determine why-so a "bed pillow was cut up" and used to raise the deflated area of the cushion until they arrived back home.Reportedly, the end user has a history of receiving pressure injuries, noting that this is his 3rd one.The caller states that the end user has a hard time finding a cushion that works for him properly.It is reported that the end user was hospitalized due to an infection and a fever of 103.3, while also having a pressure injury.The caller is unsure about how long the end user was sitting on the deflated cushion due to the end user being secretive about his self-care.Recently, it was confirmed that the end user is home, and that they have stabilized per physicians.The caller states that the end user has a hard time finding a cushion that works for him properly, and that he feels the immersion function of the current cushion makes him sink in too much.It was suggested that the end user see a seating specialist as soon as possible to ensure that positioning is appropriate.A replacement cushion was sent to the caller and a return label was given so that the cushion of concern could be evaluated.As of 10/18, the cushion has not been received.Per caller, daily hand checks as detailed in the manual, were not being conducted.The end user is replacing his wheelchair and has arranged for a seating specialist to come out to ensure that the chair is a proper fit for him, and then to complete the initial set up of the replacement cushion that was received.Subsequent check-ins with the caller have all returned positive progress notes, and the end user continues to offload throughout the day until consultation with the seating specialist has occurred.Although an alleged injury is reported, no medical documents have been submitted for confirmation.A dhr review is being conducted and information will be added to the physical complaint file.If additional contact is made with the end user or if additional information is obtained, then the information provided will be updated.Initial submission attempt was made on friday, october 21st.However, due to technical difficulties the esg helpdesk was needed.Response from the esg helpdesk occured on monday, october 21st, and so report was submitted.Update- the end users cushion was evaluated.Evaluation report will be attached to the submitted report.The inflation valve was discovered to be dislodged from the cushion when it was returned for evaluation.The valve becoming dislodged from the cushion occurred in the field under intended use.As part of the quality inspection process, all cushions are inspected in an over-inflated state.Had this defect occurred while at the facility, the cushion would not have passed inspection.The valve being dislodged from the cushion, while the isoflo valve was locked caused one quadrant to deflate.This would have been the front quadrant nearest to the valve.Per the customers statements, the alleged injury occurred due to the rear quadrant of the cushion being deflated.Based on evaluation, the cushion was orientated backwards in the end user's seat and continuously used in a flattened state.This placed the deflated cell in a higher risk area, which if orientated properly, may have been in a lower risk area.The valve was placed back into the cushion and no further issues were discovered.Results of the dhr review showed no abnormalities with the manufacturing of the cushion.Although an alleged injury is reported, no medical documents have been submitted for confirmation.If additional information is obtained, a follow-up report will be submitted.

Event Description

Customer's fiancé called in and stated that their family went on vacation.The cushion allegedly went flat, and the end user didn't say anything initially and continued to use the cushion.Once it was discovered, the fiancé cut up a pillow and placed the pieces under the end user since the back quads of the cushion were not holding air.End user was taken to the hospital upon arriving home.Fiancé stated that end user had a big pressure sore and a 103.3-degree fever.

Manufacturer Narrative

The fiancé of the end user alleges that he has developed a large pressure injury following the extended use of a deflated cushion.Per the finance, his cushion went flat while the family was travelling, and once he advised them, they were unable to determine why-so a "bed pillow was cut up" and used to raise the deflated area of the cushion until they arrived back home.Reportedly, the end user has a history of receiving pressure injuries, noting that this is his 3rd one.The caller states that the end user has a hard time finding a cushion that works for him properly.It is reported that the end user was hospitalized due to an infection and a fever of 103.3, while also having a pressure injury.The caller is unsure about how long the end user was sitting on the deflated cushion due to the end user being secretive about his self-care.Recently, it was confirmed that the end user is home, and that they have stabilized per physicians.The caller states that the end user has a hard time finding a cushion that works for him properly, and that he feels the immersion function of the current cushion makes him sink in too much.It was suggested that the end user see a seating specialist as soon as possible to ensure that positioning is appropriate.A replacement cushion was sent to the caller and a return label was given so that the cushion of concern could be evaluated.As of (b)(6), the cushion has not been received.Per caller, daily hand checks as detailed in the manual, were not being conducted.The end user is replacing his wheelchair and has arranged for a seating specialist to come out to ensure that the chair is a proper fit for him, and then to complete the initial set up of the replacement cushion that was received.Subsequent check-ins with the caller have all returned positive progress notes, and the end user continues to offload throughout the day until consultation with the seating specialist has occurred.Although an alleged injury is reported, no medical documents have been submitted for confirmation.A dhr review is being conducted and information will be added to the physical complaint file.If additional contact is made with the end user or if additional information is obtained, then the information provided will be updated.Initial submission attempt was made on friday, (b)(6).However, due to technical difficulties the esg helpdesk was needed.Response from the esg helpdesk occured on monday, (b)(6), and so report was submitted.Update- the end users cushion was evaluated.Evaluation report will be attached to the submitted report.The inflation valve was discovered to be dislodged from the cushion when it was returned for evaluation.The valve becoming dislodged from the cushion occurred in the field under intended use.As part of the quality inspection process, all cushions are inspected in an over-inflated state.Had this defect occurred while at the facility, the cushion would not have passed inspection.The valve being dislodged from the cushion, while the isoflo valve was locked caused one quadrant to deflate.This would have been the front quadrant nearest to the valve.Per the customers statements, the alleged injury occurred due to the rear quadrant of the cushion being deflated.Based on evaluation, the cushion was orientated backwards in the end user's seat and continuously used in a flattened state.This placed the deflated cell in a higher risk area, which if orientated properly, may have been in a lower risk area.The valve was placed back into the cushion and no further issues were discovered.Results of the dhr review showed no abnormalities with the manufacturing of the cushion.Although an alleged injury is reported, no medical documents have been submitted for confirmation.If additional information is obtained, a follow-up report will be submitted.Additional update- on (b)(6) 2020 a 45 day response letter was received from the fda requesting additional information regarding this complaint and one other.A response was drafted and submitted on (b)(6) 2020.A copy of the response will be attached.Jmc - attachment: [complaint (b)(4)].

Event Description

Customer's fiancé called in and stated that their family went on vacation.The cushion allegedly went flat, and the end user didn't say anything initially and continued to use the cushion.Once it was discovered, the fiancé cut up a pillow and placed the pieces under the end user since the back quads of the cushion were not holding air.End user was taken to the hospital upon arriving home.Fiancé stated that end user had a big pressure sore and a 103.3-degree fever.

• Brand Name: ROHO QUADTRO SELECT LOW PROFILE CUSHION
• Type of Device: WHEELCHAIR CUSHION
• Manufacturer (Section D): ROHO, INC.; 1501 s. 74th street; belleville IL 62223
• MDR Report Key: 9215715
• MDR Text Key: 163122954
• Report Number: 1419507-2019-00005
• Device Sequence Number: 1
• Product Code: KIC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QS910LPC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other