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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 VENTILATOR, CONTINUOUS, FACILITY USE

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CAREFUSION, INC PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number REVEL VENTILATOR
Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem Vascular Dissection (3160)
Event Date 03/30/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Any additional information provided by the customer will be included in a follow up report. (b)(4). The suspect device was evaluated on site by a biomedical engineer. The unit passed the power on self-test but failed the circuit test. The biomedical engineer determined the turbine would not operate. Results of investigation: carefusion certified service technician was able to verify the customer's reported issue. Bench testing revealed the blower module was not functioning. The service technician replaced the blower module and the reported issue was resolved. The unit passed all testing and met all carefusion manufacturer specifications.

 
Event Description

It was reported to carefusion that revel ventilator displayed error code fs and did not have any output. At this time, it is unknown if there was any patient involvement associated with the reported issue.

 
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Brand NamePALMTOP VENTILATOR, MODELS PTV-8, PTV-10
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
CAREFUSION, INC
22745 savi ranch parkway
yorba linda CA 92887
Manufacturer (Section G)
CAREFUSION, INC
17400 medina road
suite 100
plymouth MN 55447
Manufacturer Contact
kristin graf
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key6532170
MDR Text Key74177626
Report Number2031702-2017-01774
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK070594
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 04/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/28/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREVEL VENTILATOR
Device Catalogue Number19260-001
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/11/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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