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

Model Number V60

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 14oct2020.

Event Description

The customer reported the unit shutdown when the patient was being transported from the room.The customer confirmed the reported unit shutdown when running on battery only while transporting the patient from the room.The unit showed battery not installed when the battery was installed.The customer indicated the district office found that the unit did not recognize the battery, installed a known working battery and vent then recognized battery and displayed battery information in the service mode/ventilator information screen.They validated that the power management board and related circuitry of the ventilator are operating properly.Battery replacement and final testing are in process.The device was reported to be in clinical use when patient was being transported from the room at the time the reported issue was discovered and the unit was swapped out; however, there was no reported patient or user harm.

Manufacturer Narrative

Multiple attempts were made to follow up with the customer to obtain information regarding the repair and operational status with no response from the reporter and cannot be determined.If additional information is later obtained, a supplemental report will be submitted.

Manufacturer Narrative

The battery was found to be defective it was later confirmed by the customer that the battery was replaced, and the issue was resolved.The device was returned to service.

• 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: 10681333
• MDR Text Key: 213467566
• Report Number: 2031642-2020-03730
• 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: 07/08/2022

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: 09/25/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 06/02/2022; 06/27/2022
• Supplement Dates FDA Received: 06/10/2022; 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER