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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 Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
The manufacturers failure investigation technician reported the blower motor shaft stuck and does not spin (1201 e/c).No patient involvement.
 
Manufacturer Narrative
Date of event: (b)(6) 2018.Date of report: 24sep2018.Performed the blower motor troubleshooting procedure and the blower motor failed to spin by hand and on the trilogy test bed.This failure is indicative of bearing failure and he part was replaced.This failure has been identified and investigated under capa (b)(4).
 
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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
MDR Report Key7168576
MDR Text Key96613875
Report Number2031642-2018-00032
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 07/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberV60
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2017
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/15/2017
Initial Date FDA Received01/05/2018
Supplement Dates Manufacturer Received12/18/2017
Supplement Dates FDA Received09/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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