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

Model Number V60

Device Problem No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 23sep2020.

Event Description

It was reported there was no flow.It is unknown if the unit was in use on a patient.

Manufacturer Narrative

G4:16dec2020.B4: 06jan2021.The ventilator was being placed on a patient for use when it was noted there was no flow.Multiple good faith efforts were made to determine the outcome of the patient and whether there was any intervention, however it remains unknown.The field service engineer (fse) detected leaks in the flow assembly.The fse replaced the data acquisition board, the blower, and the flow sensor assembly.The issue was resolved and the device was returned to service.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

The data acquisition board was received by the manufacturer and was evaluated.The out-of-specification u1 on the air flow sensor pcba created the air flow accuracy test to fail.

Manufacturer Narrative

The data acquisition (da) pcba, gas delivery system (gds) and blower assembly were received for evaluation.The data acquisition (da) pcba was tested and no failures were identified.The gas delivery system (gds) assembly and blower assembly was installed in the fi test ventilator in an attempt to duplicate the reported complaint of no flow.The out of specification u1 on the air flow sensor pcba created the air flow accuracy test to fail.

• 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: 10575568
• MDR Text Key: 208718867
• Report Number: 2031642-2020-03424
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2012
• 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