MAUDE Adverse Event Report: KAP MEDICAL DRIVE MEDICAL; MATTRESS

Model Number LS9500

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 10/20/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a lateral rotation mattress, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The end user of the unit reported that the "pump is constantly running and will not fill the area where she is lying".The end user reportedly now has 5 bed sores, which are being treated by her home health aide.Drive did not receive any information regarding the patient's overall pressure injury management program.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE MEDICAL
• Type of Device: MATTRESS
• Manufacturer (Section D): KAP MEDICAL; 1395 pico street; corona CA 92881
• MDR Report Key: 16112062
• MDR Text Key: 306793518
• Report Number: 2438477-2022-00130
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00822383257471
• UDI-Public: 822383257471
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LS9500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2023
• Distributor Facility Aware Date: 11/03/2022
• Device Age: 18 MO
• Date Report to Manufacturer: 01/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 59 KG