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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) 2018. Date of report: 03oct2018. The customer reported the unit was run at high blower speed for several hours with out alarm or failure indications. The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed, back in service.

 
Event Description

The customer reported that the device displayed an error code "blower temperature high". The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user. The event date was not specified; estimate used.

 
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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)
RICA
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
lisa cardenas
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key7932252
MDR Text Key122651994
Report Number2031642-2018-02067
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 09/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/03/2018
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 Received09/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/04/2010
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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