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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 Operating System Becomes Nonfunctional (2996)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 11jun2020.
 
Event Description
It was reported that the unit had a touchscreen failure (frozen screen).The device was in use at the time of the event; however, there was no patient harm.The manufacturer's remote service technician performed troubleshooting with the customer.The customer reported they were able to calibrate the touchscreen and requested the part information for a touchscreen.
 
Manufacturer Narrative
G4: 06jul2020.B4: 06jul2020.The customer reported back to the remote service engineer that they cleaned the touchscreen with cleaner and the issue was resolved.The device remains in use at the customer site.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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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 Key10146677
MDR Text Key195369150
Report Number2031642-2020-02069
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
Report Date 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2020
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 Received05/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
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