MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MATTRESS,SYSTEM,SUPRA DPS,LAL/ALT. P

Catalog Number	MDT24SUPRADPS
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿her mattress the first 4 days it was working properly, after the fifth night mattress was inflated but not in full¿ and ¿she checked all connections and all is connected properly but not inflation in full.¿.
Additional Manufacturer Narrative
It was reported that the product problem/issue was not inflating; the complaint transcript states the mattress was working properly for the first 4 days and, after the fifth night, was inflated but not in full, with all connections connected properly but not inflation in full.Medline inflated the mattress with the pump provided and found no issues; the mattress inflated fully, soapy water was sprayed on the cell seams and found no leaking air, and all connectors were attached with no leaking air.The sample provided complaint has not been confirmed, and the cause was not confirmed with received sample.There was no reported death or serious injury associated with this event, and review of the complaint information as well as the results of the investigation indicated no need for further action at this time.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-MATTRESS,SYSTEM,SUPRA DPS,LAL/ALT. P
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947088
• Report Number: 1417592-2026-54389
• Device Sequence Number: 13349381
• Product Code: FNM
• UDI-Device Identifier: 40080196372196
• UDI-Public: 40080196372196
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K933965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MDT24SUPRADPS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/06/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female