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U.S. Department of Health and Human Services

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

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RESPIRONICS CALIFORNIA, INC V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
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.

 
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Brand NameV60 VENTILATOR
Type of DeviceVENTILATOR, 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 Key7307650
MDR Text Key101405922
Report Number2031642-2018-00453
Device Sequence Number1
Product Code MNT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK082660
Number of Events Reported1
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 Received03/01/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberV60
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/21/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/02/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/11/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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