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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 Problem Volume Accuracy Problem (1675)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2018.Date of report: 17sep2019.The manufacturer¿s international service technician confirmed the reported airflow issue.The manufacturer¿s international service technician replaced the flow sensor assembly to address the reported problem.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.Airflow sensor drift caused unit to pass out of specified range.Replacement of u1/u2 combination of airflow sensor subsystem resulted in the unit passing all testing.Root cause failure determined to be fault in u1 of airflow subsystem.Mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.
 
Event Description
Air flow accuracy test failed fse confirmed air flow accuracy 0 offset out of specification and returned gds unit for analysis.The customer reported there was no patient involvement.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, 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 Key9078847
MDR Text Key191723664
Report Number2031642-2019-09631
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2018
Was the Report Sent to FDA? No
Date Manufacturer Received10/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age90 YR
Patient Weight38
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