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

Model Number V60

Device Problem Defective Alarm (1014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 31jul2020.

Event Description

The customer reported that the ventilator experienced an alarm light emitting diode (led) failure.The device was not in clinical use at the time the issue was discovered.There was no patient or user harm reported.The manufacturer's international service technician evaluated the device, duplicated, and confirmed the reported issue upon powering on the device.Upon power on the device displayed an error consistent with the primary alarm failure.The service technician has ordered a replacement cpu (central processing unit) board.The technician will wait for the repair to be complete because cpu boards are on backorder.

Manufacturer Narrative

G4: 09sep2020.B4: 14oct2020.The reported alarm led failed was unable to be confirmed in the event log or via operational check.Further assessment revealed that a ''primary alarm failed'' occurred.The device was said to have been in clinical use when the event was discovered.The failure occurred before a patient was put on the unit.To address the primary alarm failure, the philips international field service engineer (fse) replaced the speaker and the central processing unit (cpu) board controlling the speaker.The unit was functionally tested and successfully passed all testing.The unit was returned to service.No other abnormality was observed.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: 29oct2020 b4: (b)(6) 2020.The central processing unit (cpu) printed circuit board assembly (pcba) (pcba, cpu, v680) was returned for evaluation.Visual inspection of this customer returned cpu pcba revealed no anomalies.A failure investigation (fi) technician installed the cpu pcba into a fi ventilator to duplicate the reported issue of primary alarm failure.The fi technician identified the failure of capacitor c205 caused the primary alarm failure.Additionally, the alarm led functioned properly during testing 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: 10353670
• MDR Text Key: 202536221
• Report Number: 2031642-2020-02601
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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: 10/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1