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

Model Number V60

Device Problems Defective Alarm (1014); Operating System Becomes Nonfunctional (2996)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 09nov2020.

Event Description

It was reported to philips that the device had primary alarm failed alarm.The screen was frozen while a patient was on the unit and the alarm didn't stop sounding.The device was reported as being in use at the time of the event on a patient.The initial reporter confirmed that there was no adverse patient impact.

Manufacturer Narrative

G4:01mar2021.B4:03mar2021.H11:g5:k102985.H10: the customer had a standby ventilator which was immediately connected to patient and there was no delay in therapy.A philips service engineer (se) was dispatched to the customer site.The se confirmed the reported issue was caused by a 35v supply and auxiliary alarm supply failure.The internal power of 35v had decreased to around 4v.The se replaced the motor control printed circuit board assembly (mc pcba) to resolve the issue and bring the device back to functionality.Following the repair, the device was placed back into service.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.

Manufacturer Narrative

G4:02mar2021.B4:16mar2021.There was no delay in therapy and no medical intervention was required.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: 10814132
• MDR Text Key: 217151552
• Report Number: 2031642-2020-04142
• 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: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2020

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: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 10/26/2020; 10/26/2020
• Supplement Dates FDA Received: 03/03/2021; 03/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2019
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.