MAUDE Adverse Event Report: KAP MEDICAL DRIVE MEDICAL; MATTRESS

Model Number	LS9500
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: MATTRESS
• Manufacturer (Section D): KAP MEDICAL; 1395 pico street; corona CA 92881
• MDR Report Key: 16112062
• Report Number: 2438477-2022-00130
• Device Sequence Number: 14866580
• Product Code: FNM
• UDI-Device Identifier: 00822383257471
• UDI-Public: 822383257471
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2023
• Report Date (Section F): 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: LS9500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/03/2022
• Device Age: 18 MO
• Date Report to Manufacturer: 01/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Date Report Sent to FDA: 01/06/2023