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

Catalog Number MDT24A20

Device Problem Decrease in Pressure (1490)

Patient Problem Pressure Sores (2326)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, since they received the air mattress system in "september" it has been alarming with an error message of "low pressure".The customer reported the mattress is "flat" and he has been laying on the "metal" portion of the bed.The customer reported he developed "4 pressure sores" above the buttock.The customer reported that 2 of the sores are "red with open skin" and 2 of the sores are "red with intact skin".The customer reported they have been applying "cream to prevent moisture" and repositioning him every "2-3 hours".Sample requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, since they received the air mattress system in "september" it has been alarming with an error message of "low pressure".

• Type of Device: MATTRESS,SYSTEM,A20,LAL/ALTERNATING PRES
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18464451
• MDR Text Key: 332312593
• Report Number: 1417592-2024-00016
• 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: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MDT24A20
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other