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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 Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Event date: (b)(6) 2018.Date of this report: 06dec2018.Philip's field service engineer (fse) performed remote troubleshooting with the customer.The customer was unable to duplicate the error.A follow-up report will be submitted once the investigation is completed.
 
Event Description
It was reported that the unit logged an error 1122 (high blower temperature).The device was in use at the time of the event; however, there was no patient harm.The event date was not specified; estimate used.
 
Manufacturer Narrative
Date of report: 18dec2018.Date of manufacturer: 13dec2018.The customer ran the unit for several days to monitor the ventilator operation and no errors/issue were found.The customer returned the device to service.No parts were returned to philips for investigation, therefore, a root cause could not be established.
 
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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 Key8138922
MDR Text Key130035754
Report Number2031642-2018-02717
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838020054
UDI-Public00884838020054
Combination Product (y/n)N
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
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
Was the Report Sent to FDA? No
Date Manufacturer Received11/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PATIENT CIRCUIT, MASK, HUMIDIFIER: UNKNOWN
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