MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC Medline; MATTRESS LOW AIR/ALT PRESS,DIGITAL

Model Number MDT24SUPRADPS

Device Problem Inflation Problem (1310)

Patient Problem Tissue Breakdown (2681)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the customer air mattress would not properly inflate.The end user reported he noticed the uneven pressure of the air mattress after two days.The customer stated he now has two bedsores and sought treatment with the assistance of a home health nurse.Due to the need for medical intervention and in an abundance of caution, this is an mdr reportable event.The sample is available to be returned for evaluation.If additional relevant information becomes available a supplemental mdr will be filed.

Event Description

It was reported the end user air mattress did not properly inflate, causing bedsores.

• Brand Name: Medline
• Type of Device: MATTRESS LOW AIR/ALT PRESS,DIGITAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; three lakes drive; northfield, il
• Manufacturer Contact: kathy woods ; three lakes drive; northfield, il ; 9317708
• MDR Report Key: 10141392
• MDR Text Key: 203322620
• Report Number: 1417592-2020-00063
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 40080196372196
• UDI-Public: 40080196372196
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/10/2020

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: MDT24SUPRADPS
• Device Catalogue Number: MDT24SUPRADPS
• Device Lot Number: (10)90318110914
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 152