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

Catalog Number	MDS600GOH
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "this pump will not stay on.".
Additional Manufacturer Narrative
A complaint was reported regarding the product not staying on; the incident did not occur during use and no injury occurred.Physical samples were provided by the customer, as well as photos of the labeling on the item; one of the sleeves does not charge when connected to power, there is no led flashing when plugged in (2 different charging cables used), only one of the sleeves powers on, and the sleeve that powered on was functional as intended for a period of an hr.Based on the information provided and the results of the investigation, the reported issue was confirmed; based off the vendor's response, nothing was found within any relevant records to indicate any potential contributors towards a quality issue with the manufacturing of the product.Cause was documented as cannot determine cause w/received sample, no corrective or preventative actions were implemented, and complaints are monitored via the trend analysis procedure.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: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50753804
• Report Number: 1417592-2026-39125
• Device Sequence Number: 9203211
• Product Code: JOW
• UDI-Device Identifier: 10197344098415
• UDI-Public: 10197344098415
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/09/2026

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: MDS600GOH
• Device Lot Number: MH240702001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2025
• 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: 10/01/2025
• Initial Report FDA Received Date: 09/14/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown