MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PORTABLE DVT PUMP/SLEEVE,CORDLESS,10PR

Catalog Number	MDS600GO
Medical Device Problem Codes	Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "item will work and then stop after about 5 compressions and continuosly beeps.".
Additional Manufacturer Narrative
Per customer, the pumps would stop after about 5 compressions and continuously beep; there was no death, serious injury, or medical intervention associated with this event.A sample was received and, upon visual observation, no physical defects were observed; however, when the sample was tested, the sleeve marked with an x on the pump stopped working after 4-5 compressions even though the power light was green, and after stopping, the pump continuously beeped with the error light on.The reported issue was confirmed, and the vendor stated that the reported issue was caused by a broken inner air bladder; a small hole was identified at the rf welding location, which caused air in the sleeve to leak and result in the warning/error.The vendor stated that it is difficult to determine whether the defect was caused by a manufacturing issue or by customer use.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: PORTABLE DVT PUMP/SLEEVE,CORDLESS,10PR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50805513
• Report Number: 1417592-2026-43859
• Device Sequence Number: 15602707
• Product Code: JOW
• UDI-Device Identifier: 10197344098415
• UDI-Public: 10197344098415
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K200568
• 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): 09/16/2026

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: MDS600GO
• Device Lot Number: MH240702001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/01/2026
• 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: 02/24/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Unknown