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

Model Number QS1010C

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

The end user was contacted to obtain an update for the investigation.Per the end user, they have home nurses that assist daily with monitoring their skin due to them being a quadriplegic with little/no sensation in the area surrounded by the cushion.While they are uncertain when the cushion deflated, it was noticed the morning after the cushion was used for 12 hours.Per the end user, they perform skin checks daily and the inflation levels of the cushion are checked.The end user stated that they did not notice anything abnormal with their positioning when using the cushion prior to noticing it was deflated in three of the compartments.The replacement cushion was received by the end user, and appears to be functional, although it has not been used yet.Inflation instructions were being reviewed with the end user, and the concept of a "soft immersion" made the end user believe that they had been using the cushion in an over-inflated state.The end user states that their cushion was received already inflated by the dealer, and that when in use, they sat right on top of the cells vs.Being immersed into them.These statements made by the end user support the results of the quality evaluation that was performed.Per the quality evaluation, the cushion was found to be free of manufacturing defects.However, there was localized post-delivery damage observed.The damaged to the cushion was noted to be on top of a cell.With proper immersion, the observed damaged should not have been present.The location of the hole would allow air to leak out of the 3 compartments if the isoflo valve was in a locked position, while keeping the front quadrant inflated.No other irregularities were observed.Per the end user, they have visited with their physician and are reporting to have a stage three pressure injury.Currently, the end user has had no additional treatment, but is scheduled to begin treatment at a wound care facility within the next week.The provided operation manual includes information for safety that states; "do not use an under-inflated cushion or an over-inflated cushion because the product benefits will be reduced or eliminated, resulting in an increased risk to skin and other soft tissue." while the end user confirms that hand checks were conducted daily, the cushion was also reported as being used in an over-inflated state for an extended period.Although an alleged injury is reported, no supporting medical documents have been provided.If additional information related to the complaint is obtained, a follow-up report will be submitted.

Event Description

After sitting on the cushion for 12 hours, it is alleged that a pressure injury was observed the following morning.The compartment nearest to the valve was inflated, but the other three sections were deflated.The end user has no lower sensation, but did not notice any difference in their positioning throughout the previous day.The cushion is reportedly checked daily by caregivers for inflation, and skin checks are performed according to the manual.The end user believes the cushions inflation level may not have been correct, and states that it was already inflated when it was received from the dealer.The end user also expressed that there was uncertainty regarding how to properly operate the isoflo valve on their cushion.

• Brand Name: ROHO QUADTRO SELECT HIGH PROFILE CUSHION
• Type of Device: WHEELCHAIR CUSHION
• Manufacturer (Section D): ROHO, INC.; 1501 s. 74th street; belleville IL 62223
• Manufacturer (Section G): ROHO, INC.; 1501 s. 74th street; belleville IL 62223
• Manufacturer Contact: robin gergen ; 1501 s. 74th street; belleville, IL 62223
• MDR Report Key: 9788838
• MDR Text Key: 188233776
• Report Number: 1419507-2020-00002
• Device Sequence Number: 1
• Product Code: KIC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QS1010C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other