MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. BARIAIR; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 405500-CD-R

Device Problem Short Fill (1575)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event Description

A patient developed stage 3 pressure ulcer while being on bariair bed.Customer stated they found that an air cushion in the upper section was not filled with air and the patient was laying on the bed platform.

• Brand Name: BARIAIR
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 9375268
• MDR Text Key: 168278204
• Report Number: 1419652-2019-00209
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 405500-CD-R
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/26/2019
• Distributor Facility Aware Date: 10/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 153