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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 Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Date of event: (b)(6) 2020. Date of report: 26may2020.

 
Event Description

The customer reported a high blower temperature alarm. The ventilator was being used on a patient at the time of the reported event, however, there was no patient harm. The patient's information was not provided. The patient had to be moved to a different ventilator as a result of this event. There was no additional medical intervention being required. The field service engineer (fse) evaluated the ventilator and confirmed the occurrence of the reported alarm. The fse installed new air inlet filter, cleaned the cooling fan filter, and verified that the cooling fan motor was operating within specifications. The ventilator successfully passed functionality testing after repair was completed.

 
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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
melissa abbott
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key10087992
MDR Text Key192388194
Report Number2031642-2020-01844
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
Type of Report Initial
Report Date 05/05/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberV60
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/04/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/22/2014
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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