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

Model Number T.W. POWER SUPPLY

Device Problem Failure to Deliver Energy (1211)

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

Event Date 04/06/2022

Event Type  malfunction  

Event Description

The hospital reported that the t.W.Power supply is not working.No output.No patient harm.Warranty expired may/03/2020.

Manufacturer Narrative

Trackwise id (b)(4).

Manufacturer Narrative

Trackwise # (b)(4).Corrected section: from "device not returned" to "device returned" the reported device is an oem device.The certificate of conformance was reviewed for the serial # (b)(6).The vendor certifies that this device conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.The device was returned to the factory for evaluation on 05/09/2022.An investigation was conducted on 05/24/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.An electrical evaluation was conducted.A reference power cord was attached to the power supply and the device was switched on.No green light was observed to indicate that there was power to the device.No other electrical testing was done due to no electrical power to the device.Based on the returned condition of the device, the reported failure "failure to deliver energy" was confirmed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device serial conforms to all applicable product specifications.The c of c is available for review as an attachment to the record.

• 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
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 14347163
• MDR Text Key: 291309430
• Report Number: 2242352-2022-00395
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

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 Operator: Health Professional
• Device Model Number: T.W. POWER SUPPLY
• Device Catalogue Number: C-VH-3010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1