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

Catalog Number	MDS600INT
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6), "staff could not power on the unit and submitted it to us in biomed.".
Additional Manufacturer Narrative
According to the facility on (b)(6), "staff could not power on the unit and submitted it to us in biomed.I confirmed that the unit was not powering on and proceeded to troubleshoot.Power cord, fuses, and continuity between input module, fuse board, and power board were all okay upon initial testing.Sparks could be seen specifically inside the white cable connection on the fuse board (cable coming from the power input module) and moving the black/white cables would sometimes allow power but not consistently.Reinforcing pin connections did eliminate spark but did not consistently restore power".The facility stated no patient was involved.Sparks were only visualized during technician troubleshooting.The device is available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: PUMP,DVT,INTERMITTENT,GEN1
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20624831
• Report Number: 1417592-2024-00949
• Device Sequence Number: 7552877
• Product Code: JOW
• UDI-Device Identifier: 40884389817910
• UDI-Public: 40884389817910
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MDS600INT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown