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

Model Number V60

Device Problem Device Sensing Problem (2917)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 02sep2020.

Event Description

The customer reported a ventilator that could not recognize the battery.There was no patient involvement or harm.

Manufacturer Narrative

G4: 19oct2020.B4: 20oct2020.The device was not in use at the time of the event.There was no report of patient or user harm.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer stated that the battery date was 2014-11, and verified there was no charging voltage from the pm board to the battery.The rse advised the customer to replace the battery and pm board.The customer replaced the pm board and power harness cable to resolve the reported issue and returned the defective part to philips.The battery was also replaced as it was noted to be over 5 years old which philips recommends replacing every 5 years per the service manual.G4: 13oct2020 b4: 20oct2020 the power management board assembly (assy,pcb,pwr mgmt,v680) was returned to philips for failure analysis.Visual inspection revealed no anomalies.A failure investigation (fi) technician installed the power management board into a fi ventilator to duplicate the reported.During the unit testing the power management board was installed onto known good test unit, booted unit in normal operation mode with battery and ac to check for alarms and errors.The customer complaint cannot be verified.The test ventilator recognized presence of battery with returned power management board installed.No fault found.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: 10485325
• MDR Text Key: 206313020
• Report Number: 2031642-2020-03117
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• 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: 09/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1