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

Model Number V60

Device Problem Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 09jul2020.

Event Description

The customer reported that the unit is showing the error message ¿high priority check vent: alarm led failed." the customer contacted product support and requested for service repair.The field service engineer (fse) replaced the power management board, but the unit still continue to have the same failure.The fse advised the customer to send the unit to one of philips bench repair for further troubleshooting and repair.The customer reported that the unit was not in use on a patient.

Manufacturer Narrative

G4: 22jul2020.B4: 30jul2020.The service technician reported that replacing the power switch overlay address the reported problem.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: 10sep2020.B4: 14sep2020.E1: institution name: ramsay health care.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: 13oct2020 b4: (b)(6) 2020 failure analysis on the returned power management (pm) board shows that the customer reported problem was not duplicated.Cycle testing did not replicate reported failure.All light emitting diode's (leds) operate normally.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
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 10253244
• MDR Text Key: 198860230
• Report Number: 2031642-2020-02297
• 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,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1