MAUDE Adverse Event Report: V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problems Failure of Device to Self-Test (2937); Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Reported: 24feb2021.

Event Description

It was reported to philips that the device had error speaker test (pm pcba & mc pcba) with the failure code primary alarm failed post motor speaker failed.The device was not in clinical use at the time of the event.There was no report of patient or user harm.This issue occurs during the power on self test (post).The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer stated that the power management board has been replaced and the issue continues to happen.The rse informed the customer that per service manual suspect the speaker on the motor controller pcb side.The customer stated that they ohmed both speakers out and they both passed.The rse provided the customer with the part information to order a replacement motor controller pcba.

Manufacturer Narrative

G4:23mar2021 b4:(b)(6)2021 multiple good faith efforts were made to obtain information regarding device evaluation, repair, and operational status with no response from the reporter and therefore cannot be determined.It is unknown if any parts were replaced or repair has been conducted.If new information is received, a supplemental report will be submitted.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11375756
• MDR Text Key: 234778007
• Report Number: 2031642-2021-00721
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1