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

Catalog Number MDT24A20

Device Problem Complete Loss of Power (4015)

Patient Problem Pressure Sores (2326)

Event Date 04/01/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, in the "middle of april" the pump stopped working after having it for "6 months".The customer reported he was laying on the "springs" for "a few days" and developed a "bed sore" on his "bottom".The customer reported he is out of bed during the day and is in bed only at night.The customer reported he hasn't utilized a "medical bed" since the reported issue was identified and while the bed sore was "not open" after the reported incident, it is now "open".The customer reported his "bed sore" was assessed by his physician and home health care was ordered.The customer reported home health care visits his home "twice a week" to clean and dress the "bed sore".The customer reported he is moved "every hour" while in bed and the "bed sore" is "not improving".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, in the "middle of april" the pump stopped working after having it for "6 months".

• 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: 18962103
• MDR Text Key: 338434050
• Report Number: 1417592-2024-00436
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDT24A20
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other