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

Model Number MDT24A20

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tissue Breakdown (2681)

Event Date 09/07/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2022, 'a patient was admitted to a room on an air bed'.Per the facility on (b)(6) 2022 at 1330, 'the patient was repositioned and a stage 1 pressure ulcer was noted to the right trochanter'.The facility also stated that multiple dti's were present throughout the body that according to the facility were not present upon admission.Upon repositioning the patient the facility noted that the air mattress was noted to be sinking in the middle of the bed, and were unsuccessful in resolving the reported issue of under inflation after adjusting the settings, evaluating the pump, and assessing the mattress for leaks.Per the facility the patient was transferred to an alternate air mattress and received wound care to the reported dti's and stage one pressure ulcer.Per the facility, skin checks are performed every 3-4 hours and they had utilized pillows to assist in offloading pressure.The device is available but has not been returned for evaluation.No additional information is available at this time.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.

Event Description

According to the facility on (b)(6) 2022, 'a patient was admitted to a room on an air bed'.Per the facility on (b)(6) 2022 at 1330, 'the patient was repositioned and a stage 1 pressure ulcer was noted to the right trochanter'.

• 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: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15719900
• MDR Text Key: 302920766
• Report Number: 1417592-2022-00212
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MDT24A20
• Device Catalogue Number: MDT24A20
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/07/2022
• 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
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 45 KG