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)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes 2 malfunction events that occurred during q1 2025 ((b)(6) , 2025).The account reported that a mattress system exhibited incomplete inflation, with individual air cells not inflating fully during operation.The customer requested servicing, repair, or replacement of the affected device due to the reported loss of support performance.A mattress information form was requested to obtain additional details regarding the affected unit; however, the completed form was not received.The complaint was subsequently assigned for lot and serial number review.No patient age, weight, sex, race, or ethnicity information was available.No patient or user injuries were reported.
Additional Manufacturer Narrative
This vmsr submission is part of a retrospective data remediation review.The included events represent 2 malfunction events that medline became aware of during q1 2025 ((b)(6) , 2025).Associated lot numbers are (b)(6) and (b)(6).One mdt24supradps mattress system was evaluated following reports that individual air cells were not inflating completely.The customer requested repair or replacement due to loss of mattress support performance.No physical sample was returned for evaluation.The product has since been discontinued and is no longer supplied by the original vendor.Based on the available information, the reported malfunction could not be confirmed.Because no sample was received, medline quality was unable to perform visual inspection, functional testing, or determine whether the device failed to meet specifications.During retrospective remediation activities, the cause code was updated to unconfirmed defect - sample required to determine cause.Review of the available information determined that additional investigation would require return of the complaint sample.Of the events summarized, 0 devices were returned for evaluation.The devices' labeled single-use status was not available, and no devices were identified as reprocessed or reused.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: veera karravula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931887
• Report Number: 1417592-2026-52972
• Device Sequence Number: 15834103
• Product Code: FNM
• UDI-Device Identifier: 40080196372196
• UDI-Public: 40080196372196
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• 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
• 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: 02/20/2025
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown