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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); Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Customer reported 1122 blower overheating the customer reported there was no patient involvement.

 
Manufacturer Narrative

The manufacturer¿s field service engineer (fse) confirmed the reported issue. The manufacturer¿s field service engineer (fse) replaced the fan 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 not being used for treatment when the reported event occurred, 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.

 
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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
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key7315289
MDR Text Key101664248
Report Number2031642-2018-00497
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 02/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberV60
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/07/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/30/2015
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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