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

Model Number V60 PLUS

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020, date of report: 07dec2020.

Event Description

It was reported to philips that the device displayed an error message that the blower temperature was high.The device was in clinical use at the time of the event.There was no report of patient or user harm.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The rse informed the customer that the error code means that the blower temperature was greater than 95ºc for longer than 60 seconds.The rse advised the customer to verify that the air inlet filter was not dirty or blocked, and also to verify that the cooling fan is operational.If the issue is not resolved the rse informed the customer the blower and/or motor controller pcba would then need replacement.The customer stated the error only appeared once and has not returned.The device remains in service and will be continued to be monitored.No parts were ordered or service requested and the case was closed.

Manufacturer Narrative

G4: 08dec2020, b4: 08dec2020.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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; carlsbad CA
• Manufacturer Contact: bill cole ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 10961996
• MDR Text Key: 220469167
• Report Number: 2031642-2020-04418
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838089280
• UDI-Public: (01)00884838089280
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102985
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60 PLUS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2020
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER