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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); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Patient information not provided. Date of event: (b)(6) 2018. International udi: (b)(4). Philip's field service engineer (fse) evaluated the device and the issue was confirmed. The blower was replaced to address the event. The unit was functionally tested and returned to service.

 
Event Description

The customer reported that the blower is not functioning correctly. The unit was being used on a patient at the time the reported issue occurred; however, there was no patient harm. The event date was not specified, estimate used.

 
Manufacturer Narrative

Date of report: 26sep2018. Date received by manufacturer: 24sep2018. Updated coding. The blower motor assembly was returned to philips for investigation. Visual inspection revealed no signs of damage or contamination. The blower was installed into a test ventilator. No failures were produced and no errors were observed in the logs, therefore, a root cause could not be established.

 
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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 Key7744836
MDR Text Key116050320
Report Number2031642-2018-01541
Device Sequence Number1
Product Code MNT
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 08/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberV60
Device Catalogue Number1053617
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/31/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/05/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/20/2009
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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