MAUDE Adverse Event Report: INVACARE INVACARE CAREGUARD; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number CG9701

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 12/25/2017

Event Type  Death  

Event Description

The patient was in bed.A fire started in or on the patients bed.The patient was unable to call for help or get out of bed and sustained serious burns about his body which resulted in his untimely death.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INVACARE CAREGUARD
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17532565
• MDR Text Key: 321039426
• Report Number: MW5139473
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: CG9701
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1