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

Model Number V60

Device Problem Device Alarm System (1012)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 19oct2020.

Event Description

The customer reported a ventilator with a backup alarm failure alarm.The device was being tested with the event occurred.The device was not in clinical use at the time the issue was discovered.There was no patient or user harm reported.

Manufacturer Narrative

G4:20nov2020, b4:24nov2020.The customer reported experiencing a backup failure alarm on a ventilator during testing.The international philips field service engineer (fse) replaced the (cpu) board equipped with the power led.Additionally, a power (green/orange) led illumination failure was observed and the power switch overlay was replaced.The device was then tested and passed specification tests.No other anomalies were reported.Based on information provided and service performed, the customers alleged malfunction was confirmed, or failed to meet specifications.Device service was performed and unit worked according to specifications prior to being released.No parts were returned for failure investigation; therefore, the root cause at the component level could not be determined.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

G4:16jan2021.B4:22jan2021.The visual inspection of the customer returned central processing unit (cpu) printed circuit board assembly (pcba) assembly revealed no anomalies.A failure investigation (fi) technician installed the cpu pcba into a fi ventilator to duplicate the reported issue of backup failure alarm.The fi technician identified backup failure alarm was caused by a failure in the ls1.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: 10702262
• MDR Text Key: 213677249
• Report Number: 2031642-2020-03774
• 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: 09/29/2020

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: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 09/29/2020; 09/29/2020
• Supplement Dates FDA Received: 11/25/2020; 01/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• 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