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 Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 08jan2021.

Event Description

The customer reported a ventilator a proximal pressure sensor auto zero failure during clinical use.The device was reported to have been in clinical use at the time the issue was discovered.There was no patient or user harm reported.

Manufacturer Narrative

The device was evaluated by the customer and a philips field service engineer (fse).Additional information was requested from the customer.No further response was received.The fse confirmed the reported issue occurred.It was reported that the fse replaced the data acquisition (da) printed circuit board assembly (pcba).The reported device was have been repaired, passed required testing nd returned for service.No other anomalies were reported.The da pcba was returned to the manufacturing for evaluation.The visual inspection of the customer returned da pcba revealed no evidence of damage or contamination.A failure investigation (fi) technician installed the da pcba into a fi ventilator to duplicate the reported issue of proximal pressure sensor auto zero failed (e/c 110b).The fi technician tested the part and no failures were identified.

Manufacturer Narrative

G4 of initial report: july 28, 2020 upon further investigation, it was discovered that this issue had a duplicate complaint that was also reported through mfr.Report # 2031642-2020-02843 which has a date received by manufacturer of 7/28/2020.Mfr.Report # 2031642-2020-02843 will be redacted as a duplicate report due to the reason that this report, mfr.Report # 2031642-2021-00093, has complete information, including failure investigation result.The initial report's date received by manufacturer is changed from 12/14/2020 to 7/28/2020.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; carlsbad CA
• Manufacturer Contact: bill cole ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11142549
• MDR Text Key: 227576802
• Report Number: 2031642-2021-00093
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2013
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER