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

Model Number V60

Device Problems Calibration Problem (2890); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

Report date: 02sep2021.There was no patient involvement.

Event Description

It was reported to philips that the device had a 35-volt supply failure.The device was not in clinical use at the time of the event.There was no report of patient or user harm.

Manufacturer Narrative

B4:24sep2021.H11:b5: it was reported to philips that the device had a data acquisition printed circuit board assembly (da pcba) adc failure and a blower high temperature error.H10: a philips field service engineer (fse) was dispatched to the customer site.The reported issue was confirmed, and it was determined that the data acquisition printed circuit board assembly (da pcba) and motor control printed circuit board assembly (mc pcba) needed to be replaced to return the device to working condition.The fse replaced the da pcba and mc pcba to resolve the issue and bring the device back to functionality.Following the repair, the device was returned to the customer to be placed back into service.

Manufacturer Narrative

The data acquisition (da) pcba and motor controller (mc) pcba were returned for analysis.Visual inspection of all returned parts revealed no evidence of damage or contamination.A failure investigation (fi) was performed.The data acquisition (da) pcba and motor controller (mc) pcba were installed in the fi test ventilator in an attempt to duplicate the reported problem.The customer complaint was verified.The root cause is a failure of mc spi transmitter ic u10.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12417878
• MDR Text Key: 270326083
• Report Number: 2031642-2021-04797
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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

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: Other
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/06/2021
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 08/26/2021; 02/17/2022
• Supplement Dates FDA Received: 09/24/2021; 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2021
• 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