MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; MATTRESS,SYSTEM,SUPRA APL,LAL/ALT. PRESS

Model Number MDT24SUPRAAPL

Device Problem Pressure Problem (3012)

Patient Problem Pressure Sores (2326)

Event Date 02/01/2022

Event Type  Injury  

Event Description

It was reported by the customer that the alternating pressure air mattress is not maintaining pressure and the customer is experiencing a reoccurrence of bed sores.

Manufacturer Narrative

It was reported by the customer that the alternating pressure air mattress is not maintaining pressure and the customer is experiencing a reoccurrence of bed sores.Per the customer the spouse who is experiencing the bed sores had spinal surgery in an attempt to restore her ability to ambulate at the end of 2020, and had stage 2 pressure sores at the base of her spine.An alternating pressure air mattress was then used and according to her husband the bed sores improved.The husband is stating that the bed is no longer maintaining pressure and the pressure sores worsened.The sample is available and has been returned for evaluation.A definitive root cause could not be determined as the pump passed all functional tests.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,SUPRA APL,LAL/ALT. PRESS
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13667530
• MDR Text Key: 286576571
• Report Number: 1417592-2022-00025
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 10080196372164
• UDI-Public: 10080196372164
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT24SUPRAAPL
• Device Catalogue Number: MDT24SUPRAAPL
• Device Lot Number: 02620080267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 61 KG