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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 Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.Complete address and phone number not provided by customer.
 
Event Description
The customer reported that the touchscreen didn't not work.There was no patient involvement.
 
Manufacturer Narrative
Date of report: 11dec2018.Date received by manufacturer: 06dec2018.The touchscreen assembly was tested and no failures were identified.
 
Manufacturer Narrative
Date of manufacturer: 08/13/2018.Date of report: 09/24/2018.The service technician replaced the touchscreen and the user interface (ui) pcba to address the reported issue.The ventilator is back in service.
 
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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 Key7626845
MDR Text Key112248537
Report Number2031642-2018-01257
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,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2018
Was the Report Sent to FDA? No
Date Manufacturer Received05/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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