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

Model Number V60

Device Problems Defective Alarm (1014); Loss of Power (1475); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2021.(b)(6) 2021.

Event Description

A customer reported to philips that while in use on a patient, the respironics v60 ventilator stopped running, did not generate any alarms, and the hospital staff placed the patient on another ventilator.The customer reported that the unit was in use on a patient at the time of the reported device behavior and medical intervention.

Manufacturer Narrative

B3: 25jan2021.B4: 25jan2021.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

G4:26jan2021.B4:27jan2021.The customer reported that the unit was in use on a patient at the time of the reported device behavior.No adverse event was reported or associated with the use of this device.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

Based on re-evaluation, this complaint has been downgraded from a serious injury to product problem as there was no other intervention rendered other than transitioning the patient to a secondary ventilator.There was no harm or injury to the patient.The institutional physician entered the patient's room and identified that the v60 ventilator was not running and alarming while hooked up to the patient.The unit would not power on in ventilation or diagnostic mode.The amber light was illuminated in the power switch.The respiratory therapist (rt) replaced the ventilator, and no patient harm was reported.The institutional biomedical engineer (bme) removed the ac and dc power, then reconnected ac power, and the unit was powered on in ventilation mode and alarms.The bme was unable to duplicate the symptom.The power and motor speakers passed as per the diagnostic code of 5021.There were a series of tidal volume alarms, the last being on 01/13 at 10 am, adjusted to 8:30 am as time was off on the vent.As the device issue could be from a possible pm pcba issue, the customer had requested field repair on unit for pm pcba for replacement.If additional information becomes available at a later date, a supplemental report will be submitted.

• 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: 11223714
• MDR Text Key: 229866049
• Report Number: 2031642-2021-00283
• 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,Followup
• Report Date: 03/16/2022

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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 01/14/2021; 01/14/2021; 03/08/2022
• Supplement Dates FDA Received: 01/25/2021; 01/27/2021; 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2012
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.
• Patient Outcome(s): Required Intervention