MAUDE Adverse Event Report: INVACARE INVACARE 36X80 APM/LA L MATTRESS, MICROCAIRAPM/LAL CONTROL UNIT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number MA85

Device Problem Smoking (1585)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2019

Event Type  Injury  

Event Description

Joerns received a call from the facility that the control unit was smoking.The patient was in the room on the mattress when this occurred.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INVACARE 36X80 APM/LA L MATTRESS, MICROCAIRAPM/LAL CONTROL UNIT
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17525484
• MDR Text Key: 321083826
• Report Number: MW5132425
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: MA85
• Patient Sequence Number: 1