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

Device Problem Inflation Problem (1310)

Patient Problem Fall (1848)

Event Date 09/08/2019

Event Type  Injury  

Event Description

The mattress got too inflated and patient fell out of the bed.Heard the patient scream, the nurse ran to room and the patient was on the floor.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INVACARE 36X80 APM/LAL MATTRESS, MICROCAIRAPM/LAL CONTROL UNIT
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17532939
• MDR Text Key: 321147602
• Report Number: MW5139845
• 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: 09/27/2019

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
• Patient Sequence Number: 1
• Patient Age: 64 YR