MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC T.W. POWER SUPPLY; UNIT, CAUTERY, THERMAL, AC-POWERED

Model Number T.W. POWER SUPPLY

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

Hospital reported t.W.Power supply s/n (b)(4) went for repair in biomed.Box was physically broken.Biomed could not repair.It is out of warranty and will be discarded.No patient involvement.

Manufacturer Narrative

H3 correction: changed to device has been discarded.H6 correction: changed to device discarded.Internal complaint number: (b)(4).A lot history search is not applicable because this is a reusable, oem device.Due to the age of the device, a c of c is not readily available on-site.

Event Description

Hospital reported t.W.Power supply s/n (b)(6) went for repair in biomed.Box was physically broken.Biomed could not repair.It is out of warranty and will be discarded.No patient involvement.

• Brand Name: T.W. POWER SUPPLY
• Type of Device: UNIT, CAUTERY, THERMAL, AC-POWERED
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• MDR Report Key: 11593345
• MDR Text Key: 243131913
• Report Number: 2242352-2021-00240
• Device Sequence Number: 1
• Product Code: HQO
• UDI-Device Identifier: 00607567700826
• UDI-Public: 00607567700826
• Combination Product (y/n): N
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T.W. POWER SUPPLY
• Device Catalogue Number: VH-3010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2021
• Patient Sequence Number: 1