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

Model Number V60

Device Problem Failure to Zero (1683)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 12dec2019.

Event Description

It was reported that the ventilator produced a diagnostic code related to machine pressure sensor autozero failure.The ventilator was being used at the time of the reported event, however, there was no patient harm.The manufacturer¿s international service technician evaluated the ventilator and determined that the data acquisition printed circuit board assembly (da pcba) required replacement.The service technician replaced the da pcba and the problem was resolved.

Manufacturer Narrative

Date rec¿d by mfr: 16dec2019, date of report : 19dec2019.The customer did not provide the patient's information.There was no report of medical intervention required as a result of this event.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: 13feb2020 b4: (b)(6) 2020.The replaced data acquisition printed circuit board assembly (da pcba) was returned for failure analysis.The da pcba was tested and no failures were identified.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: 9459348
• MDR Text Key: 193683853
• Report Number: 2031642-2019-10832
• 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: 11/27/2019

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: 02/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 11/27/2019; 11/27/2019
• Supplement Dates FDA Received: 12/19/2019; 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER