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

Model Number V60

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: 10dec2020.

Event Description

It was reported to philips that while in use on a patient, the device displayed a check vent alarm for the blower temperature high.The device was in use at the time of the event.The ventilator was swapped and there was no report of patient or use harm.The device was evaluated by the caller (biomed) with assistance from a philips remote service engineer (rse).The biomed stated that error code 1122 was logged for the blower temp high alarm in the event log, and that while troubleshooting the unit also gave a backup alarm error, code 1104.The biomed verified that the inlet filter was not dirty/clogged and the cooling fan was operational.The rse advised the customer to replace the blower assembly to resolve the error code (blower temp) and possibly replacing the power management pcba or cpu pcba for the code (back up alarm).The customer contacted the philips rse on 04-dec-2020 stating that the device was run for a few days and was not able to duplicate the issue.The biomed stated they will monitor the device for the alarms mentioned, but the ventilator seems to be working fine and was returned to service.If the decision is made to have the device evaluated and repaired a new service order will be opened and will be captured through philip's normal complaint procedure.

• 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: 10988027
• MDR Text Key: 221297848
• Report Number: 2031642-2020-04473
• 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: foreign,user facility
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• 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: 11/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• 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