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

Model Number V60

Device Problem Unexpected Shutdown (4019)

Patient Problems Injury (2348); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 31jan2021.

Event Description

Information provided by the facility clinical representative stated that during use, the device experienced a ventilator inoperative state and shutdown with no audible or visual alarms.The customer states that an rt bedside and present witnessed the device power off and attempted to power on the device again.After the reattempt to initiate therapy, the device powered off again without an audible or visual alarm.The device was then removed from use.Actions and intervention taken after the event have not been disclosed to the manufacturer.Based upon new information provided by the facility and clinical representative, the allegation of device shutdown during therapy delivery resulted in premature cessation of positive pressure therapy and an unspecified serious injury.

Manufacturer Narrative

Further good faith efforts were made to the institutional risk management department as requested by the institutional director of respiratory with no response yielded.Due to the absence of further correspondence related to the patient outcome of the event, further investigation has concluded that the no information has been supplied to the manufacturer that would indicate the presence of a serious injury occurring, nor any defined intervention being provided in order to prevent the occurrence of a serious injury.Therefore, this complaint record shall be downgraded from serious injury to an adverse event - product problem.On february 16, 2021 the v60 ventilator was retrieved from the customer site for further evaluation and investigation.Philips failure investigations confirmed the alleged malfunction occurring on date january 18, 2021.Based upon the investigation conducted, it was determined that the v60 power management printed circuit board assembly (pm-pcba) was implicated.Based upon the information provided, the device malfunction has been confirmed.The device was in clinical and therapeutic use at the time of the event, resulting in an unspecified harm.Further attempts were conducted to retrieve information regarding the extent of harm and outcomes to the patient, with no further correspondence received from the reporter.Based upon this investigation, cause and/or contribution of the unanticipated cessation of positive pressure therapy to the patient injury has been confirmed.Based upon the investigation and evaluation conducted on the v60 ventilator, the unintentional shutdown happening while complex programmable logic device (cpld) on board gets power reset during 35v(on->off-on, 35v going down to 10v and coming back to 35v) during 35v loading, does disable power source select switch (u42 ic).During this event the ventilator shuts down and does not meet 120 seconds of backup alarm.

• 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: 11256746
• MDR Text Key: 229572796
• Report Number: 2031642-2021-00381
• 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
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 01/27/2021
• Initial Date FDA Received: 01/31/2021
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2013
• 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; UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER