MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; PUMP,DVT,SEQUENTIAL, GEN2

Catalog Number	MDS600SQ2
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's original reported issue was "pumps are either physically damaged or will not turn on/stay on" on (b)(6) 2023.The pump was shipped by the customer to medline's repair center precision.It was then reported that "internal fire / explosion caused damage to all components.Yes internal components seem damaged, fuse board is melted, fuses on fuse board is blown and it had a bad scent to it." 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.
Event or Problem Description
"internal fire / explosion caused damage to all components".

• Common Device Name: PUMP,DVT,SEQUENTIAL, GEN2
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18148258
• Report Number: 1417592-2023-00450
• Device Sequence Number: 15172271
• Product Code: JOW
• UDI-Device Identifier: 10888277348103
• UDI-Public: 10888277348103
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/16/2023

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: MDS600SQ2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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