MAUDE Adverse Event Report: ROHO, INC. ROHO HYBRID ELITE SINGLE COMPARTMENT CUSHION; HYBRID ELITE, HYBRID ELITE SINGLE COMPARTMENT CUSHION, WHEELCHAIR CUSHION

Model Number R1RHE1617-SR

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event Description

Mr.(b)(6) wife alleges the cushion is always flat and has caused pressure sores.She claims he is now septic and being admitted to the hospital.She has had the cushion replaced under warranty and has contacted the dealer as well.

Manufacturer Narrative

The enduser's wife called and stated that her husband was currently hospitalized and has been in and out of the hospital multiple times over the last year due to pressure injuries from the cushion not holding air.Roho, inc, has not seen medical records to confirm this.The cushion has been in use for approximately a year with the allegation that it has not stayed inflated, but roho, inc, was unaware of the issue until this complaint.The operation manual for the cushion includes a warning that states "skin/soft tissue breakdown can occur due to a number of factors, which vary by individual.Check skin frequently, at least once a day.Redness, bruising, or darker areas (when compared to normal skin) may indicate superficial or deep tissue injury and should be addressed.If there is any discoloration to skin/soft tissue, stop use immediately.If the discoloration does not disappear within 30 minutes after disuse, immediately consult a healthcare professional." the operation manual also includes a troubleshooting section with specific information if the cushion is not holding air.It states "inflate the cushion.Inspect for damage to inflation valve(s), hose(s) and the quick disconnect (hybrid elite sr).Confirm that the inflation valve(s) are completely closed.Look for holes in the cushion.If very small holes or no holes are visible, follow the instructions in the repair kit provided with the product.For damage to the inflation valve(s), hose(s), or quick disconnect, or for large holes or leaks in the cushion, see the limited warranty supplement, or contact customer support." the cushion was not returned to roho, inc.So an evaluation could not be performed.If additional information is provided, a follow-up report will be submitted.

• Brand Name: ROHO HYBRID ELITE SINGLE COMPARTMENT CUSHION
• Type of Device: HYBRID ELITE, HYBRID ELITE SINGLE COMPARTMENT CUSHION, WHEELCHAIR CUSHION
• Manufacturer (Section D): ROHO, INC.; 1501 south 74th street; belleville IL 62223
• MDR Report Key: 12420994
• MDR Text Key: 282291678
• Report Number: 3008630266-2021-00012
• 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
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: R1RHE1617-SR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other