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

Model Number V60

Device Problems Blower (738); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

Customer reported cbit blower temperature high. The unit was in clinical use at the time the reported issue was discovered however, there was no harm to the patient or the user.

Manufacturer Narrative

The customer replaced the blower to address the reported problem. The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed, back in service the determination could not be made that the device failed to meet specifications. The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user, and there is a relationship of the device to the reported problem. Part was not returned to fi. The root cause cannot be determined until the device is returned and investigated.

Manufacturer Narrative

Date of report: 9/10/2018. Date received by manufacturer: 6/08/2018. (udi); the v60 blower assembly was returned to failure investigator (fi) lab for evaluation. Visual inspection of the blower assembly outer surface revealed no evidence of damage or contamination. The blower assembly end cap was removed and a visual inspection of the impellers and surroundings did not reveal any signs of rubbing, damage, or contamination. The blower assembly was installed into the fi test ventilator and was booted up in normal ventilation to verify the ventilator remains operational with no errors detected. No error codes were generated running the ventilator 4 hours on normal ventilation mode. The blower assembly passed all testing.

• 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; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 7307650
• MDR Text Key: 101405922
• Report Number: 2031642-2018-00453
• 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: BIOMEDICAL ENGINEER
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 03/01/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: OTHER
• Device MODEL Number: V60
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 01/11/2013
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse