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

Model Number V60

Device Problem Energy Output Problem (1431)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2020.Report date: 28dec2020.

Event Description

It was reported to philips that the device does not power on intermittently.The device was not being used on a patient at the time of the event.There was no patient or user harm reported.

Manufacturer Narrative

Device was evaluated by the customer and reported, " unit powers on intermittently and when does screen flickers and has horizontal lines." based on information provided by customer, remote service engineer advised about replacement of user interface (ui) assembly.Also provided customer with part identification (id) for ui assembly.Customer advised that he was going to swap ui assembly to see if resolves issue, but it did not.Then customer called back for part id for power management board and reported that issue was resolved with replacement of power management board.

Manufacturer Narrative

H11 (corrected data): upon further review of this record, it was determined that it is a duplicate of an event previously reported under mfr report #2031642-2020-02946.Any additional information will be submitted under the initially reported mfr report #2031642-2020-02946.

• 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: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 11041737
• MDR Text Key: 222778050
• Report Number: 2031642-2020-04640
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• 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: 10/10/2022

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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 09/19/2022; 10/06/2022
• Supplement Dates FDA Received: 09/30/2022; 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2009
• 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