MAUDE Adverse Event Report: MERIDIAN MERIDIAN U-CR EXCEL AP 36X80 MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number MERIDIAN U-CR EXCEL AP 36X80 MATTRESS, APL CONTROL UNIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Type  malfunction  

Event Description

(b)(6) called to have wider equipment delivered for pt because he continues roll and fall from bed.He's currently using a facility owned bed frame but on a rental air mattress rasaf2500.Caller was unwilling to provided any details said to reach out to manager (b)(6).Ni.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MERIDIAN U-CR EXCEL AP 36X80 MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): MERIDIAN
• MDR Report Key: 17534845
• MDR Text Key: 321222957
• Report Number: MW5141744
• 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: 10/25/2017

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: MERIDIAN U-CR EXCEL AP 36X80 MATTRESS, APL CONTROL UNIT
• Patient Sequence Number: 1