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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Fall (1848)

Event Date 11/16/2019

Event Type  Injury  

Event Description

Service call today on air mattress bolster sheet needs a sturdier one.The one he has is too loose and patient had a fall.There were no witnesses reported and no injuries to the patient.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: 17533844
• MDR Text Key: 321154307
• Report Number: MW5140747
• 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: 11/18/2019

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