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

Model Number V60

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); No Flow (2991)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.26feb2021.

Event Description

It was reported to philips that the device was not working.The device was not in clinical use at the time of the event.The nurse was setting this device up for use when the issue was found.Another device was used and there was no report of patient or user harm.A philips authorized service personnel (asp) was dispatched to the customer site.The asp found that 100% flow 10 and 140 slpm, o2 mix test failed as it would not supply any o2.The asp also found error was present on the device, device failing to deliver oxygen, and required replacement of the gds assembly.The asp replaced the gds assembly and confirmed the device passed performance and safety tests successfully.The device remains at the customer site.

Manufacturer Narrative

A gas delivery system (gds) assembly was returned for analysis.Visual inspection of the gas delivery system (gds) assembly revealed no evidence of damage or contamination.A failure investigation (fi) was performed, and the technician reported that the customer complaint could not be verified.Returned gds passes all testing.No-fault found.

• 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: 11388978
• MDR Text Key: 238397554
• Report Number: 2031642-2021-00752
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838089280
• UDI-Public: (01)00884838089280
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 06/13/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• 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