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

Model Number V60

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 22april2019.A follow-up report will be submitted once the investigation has been complete.

Event Description

The customer reported that after the exhalation port was selected as "others", the exhalation port test did not occur.There was no patient involvement.Event date not specified, estimate used.

Manufacturer Narrative

Adverse event or product problem: correction "product 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

Date of report : 21jun2019, date rec¿d by mfr : 20jun2019.The manufacturer¿s international service technician confirmed the reported port test issue.The reported phenomenon occurred due to malfunction of airflow sensor.The manufacturer¿s international service technician replaced the airflow sensor to address the reported problem.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.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

Date rec¿d by mfr : 19jul2019, date of report : 05aug2019.During further investigation (fi), failure analysis on the returned gas delivery system (gds) revealed no evidence of damage or contamination.The gds assembly revealed a defective air flow sensor on the airflow sensor pcba that was found generating the erroneous airflow average air display reading.The defective air flow sensor pcba caused the airflow accuracy test to fail.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: 8538077
• MDR Text Key: 142881614
• Report Number: 2031642-2019-02352
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• 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: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1