MAUDE Adverse Event Report: CAREMED; UNKNOWN MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number CAREMED ULTRACARE APL CONTROL UNIT, CAREMED ULTRACARE APL 35X80 MATTRESS

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 02/10/2018

Event Type  malfunction  

Event Description

Pt was sitting on the edge of the bed and slipped off.Ni.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): CAREMED; UNKNOWN
• MDR Report Key: 17531925
• MDR Text Key: 321325448
• Report Number: MW5138836
• 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: 02/26/2018

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: CAREMED ULTRACARE APL CONTROL UNIT, CAREMED ULTRACARE APL 35X80 MATTRESS
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Treatment: UNKNOWN AC-POWERED ADJUSTABLE HOSPITAL
• Patient Age: 65 YR