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

Model Number V60

Device Problems Loss of Power (1475); Failure to Power Up (1476); Electrical Power Problem (2925)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 04sep2020.

Event Description

It was reported to philips by the biomed that the device was plugged into a wall outlet and immediately shut off and will not power on.The device was in clinical use at the time of the event.The customer stated that the device was either discovered while in use on a patient or while being set up in the room for the patient.The biomed stated the device was swapped, and another v60 was placed on the patient.There was no patient harm or injury reported, and there was no additional medical intervention required.The customer evaluated the device with assistance from a philips remote service engineer (rse).The rse advised the biomed to try swapping the pm pcb or possibly the power supply.A good faith effort was made, and the biomed stated on (b)(6) 2020 that that facility believes the wall outlet was faulty.The biomed performed an evaluation on the device and determined that the power supply and battery also needed replacement.The biomed confirmed that with a new power supply, the unit powers up and appears to function normally.The battery has been ordered and will be replaced upon delivery.

Manufacturer Narrative

G4: 23nov2020, b4: 24nov2020.The biomed confirmed that with a new power supply, and battery the unit powers up and functions normally.Based on information provided and/or service performed, the customers alleged malfunction was confirmed.The device was being used for treatment when the reported event occurred.No parts were returned for failure investigation; therefore, the root cause at the component level could not be determined.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.

• 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
• MDR Report Key: 10497699
• MDR Text Key: 208599154
• Report Number: 2031642-2020-03148
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER