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

Model Number V60

Device Problem Self-Activation or Keying (1557)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 02mar2021.

Event Description

It was reported to philips that the device turned on by itself.The device was not in use at the time of the event.There was no report of patient or user harm.An international philips field service engineer (fse) was dispatched to the customer site to provide additional assistance.The fse evaluated the device and confirmed that the power management pcba (printed circuit board assembly), ui (user interface) pcba and power switch overlay required replacement.The fse replaced the power management pcba, ui pcba and power switch overlay to resolve the issue.The device successfully passed all required testing and was returned to service.

Manufacturer Narrative

The user interface pcba was returned to failure investigation for analysis.The customer complaint was verified.The root cause is contamination present on the board in the area of fb21.

Manufacturer Narrative

The power management pcba was returned to failure investigation for analysis.A visual inspection revealed no evidence of damage or contamination.The part was tested and no failures were identified.The customer's reported problem was not duplicated.

• 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): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: yobana sanchez ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 11407770
• MDR Text Key: 241314415
• Report Number: 2031642-2021-00816
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 11/30/2021

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 Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 02/03/2021; 11/03/2021
• Supplement Dates FDA Received: 07/21/2021; 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2012
• 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