MAUDE Adverse Event Report: UNKNOWN DRIVE; APP PAD

Model Number 14001E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/25/2017

Event Type  Death  

Event Description

(b)(6) healthcare is the importer of the device which is an 14001e alternating pressure overlay.The pump attached to the system was not a drive model.We are filing this report in an overabundance of caution.The deceased while subject to round the clock care was in a bed with an invacare pump and a drive 14001e alternating pressure overlay.A fire started in or around the bed.The deceased was unable to call for help or get out of the bed unassisted.He burned in the bed.The fire marshall states that the fire started due to the pump which was noted as an invacare unit.

• Brand Name: DRIVE
• Type of Device: APP PAD
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9485110
• MDR Text Key: 171779157
• Report Number: 2438477-2019-00084
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00822383135809
• UDI-Public: 822383135809
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 14001E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2019
• Distributor Facility Aware Date: 11/17/2019
• Event Location: Other
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death