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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 Failure to Calibrate (2440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 07oct2020.
 
Event Description
The customer reported that the touchscreen did not calibrate.The field service engineer (fse) confirmed the failure.The (fse) replaced the touch screen and the issue was resolved.The unit was tested and it returned to service.The unit was not in use, and there was no patient or user harm reported.
 
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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
carlsbad CA
Manufacturer Contact
bill cole
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key10643983
MDR Text Key212477348
Report Number2031642-2020-03609
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
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 Received09/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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