MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; MATTRESS,SYSTEM,A20,LAL/ALTERNATING PRES

Model Number MDT24A20

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported by the end-users mother that her daughter experienced 3 bedsores due to the mattress not staying inflated.

Manufacturer Narrative

It was reported by the end-users mother that her daughter experienced 3 bedsores due to the mattress not staying inflated.According to the mother, her daughter is a quadriplegic and bed bound.The end user stated that the mattress issue is what caused her daughter to get 3 pressure sores and she has been going in for wound care and having a home health nurse come in to pack the pressure sores for approximately 5 weeks now.The wounds are reportedly healing well.The mattress was returned to the manufacturer for evaluation and the customer reported issue was confirmed.The air cells did not reach full air capacity.A definitive root cause was not able to be established.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline
• Type of Device: MATTRESS,SYSTEM,A20,LAL/ALTERNATING PRES
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13569089
• MDR Text Key: 285922771
• Report Number: 1417592-2022-00016
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 10080196549733
• UDI-Public: 10080196549733
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT24A20
• Device Catalogue Number: MDT24A20
• Device Lot Number: 02620090327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 33 KG