MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PUMP,DVT,INTERMITTENT,GEN1

Catalog Number	MDS600INT
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pump will not turn on.
Additional Manufacturer Narrative
Customer reported that the pump will not turn on and later stated the pump was fairly new and not powering on; there was no reported death or serious injury associated with this event.Based on evaluation of the unit, precision ers noted that silicone adhesive exceeding 1 mm in thickness at the base of the ac input connector prevented the connection from establishing effectively and hindered the connector from locking securely via its latch mechanism; the silicone adhesive was removed, and the device powered on and functioned according to specifications.The reported issue was confirmed, and based on the results of the investigation, the cause of the reported issue is related to the manufacture of the product.The vendor reviewed the production process, associated records, and retained samples and did not identify any abnormalities or defects; no trends were identified.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: PUMP,DVT,INTERMITTENT,GEN1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdulrahim ghaffar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50759410
• Report Number: 1417592-2026-39765
• Device Sequence Number: 15740442
• Product Code: JOW
• UDI-Device Identifier: 40884389817910
• UDI-Public: 40884389817910
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K141064
• 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: MDS600INT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2026
• 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: 01/30/2026
• 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