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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 Calibration Error (1078)
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 customer reported that the touchscreen cannot be calibrated.There was no patient involvement.
 
Manufacturer Narrative
Product support provided part number and cost for touchscreen replacement.The reported problem was confirmed.It is unknown if the unit was repaired and in service.All follow up attempts were made.No further response provided by the customer.No patient information provided by the customer.
 
Manufacturer Narrative
Date of report: 19sep2018.Date of manufacturer: 07jun2018.The customer reported being able to perform touchscreen calibration successfully.Philip's field service engineer (fse) discussed lcd brightness, software version 2.0 and provided the customer with service manual.
 
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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 Key7169197
MDR Text Key96637901
Report Number2031642-2018-00034
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 user facility
Type of Report Initial,Followup,Followup
Report Date 12/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2018
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? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/19/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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