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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 Problems Break (1069); Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2018.Date of report: 31dec2018.(b)(4).No phone number provided.A follow-up report will be submitted once the investigation has been complete.
 
Event Description
The customer reported that the alarm silencing button is unable to press.Settings were not able to change, but calibration was performed then the setting are able to change, but alarm silencing button and alarm reset button do not work.There was no patient involvement.The event date was not specified; estimate used.
 
Manufacturer Narrative
Pma/510k: 02oct2019.Date of report: 02oct2019.The part was returned to the manufacturer for failure investigation (fi).It was determined that the ul_lr and ur_ll resistance and resistance ratio were out of specification.Fault was found on this returned touchscreen.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.
 
Event Description
The customer reported that the alarm silencing button is unable to press.Settings were not able to change, but calibration was performed then the setting are able to change, but alarm silencing button and alarm reset button do not work.There was no patient involvement.The event date was not specified; estimate used.
 
Manufacturer Narrative
Date rec'd by mfr: 15feb2019.The manufacturer¿s international service technician confirmed the reported touchscreen issue.The service technician stated that when a panel button was operated, its reaction was occasionally poor.The manufacturer¿s international service technician replaced the touchscreen to address the reported problem.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.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 Key8207307
MDR Text Key131770116
Report Number2031642-2018-03124
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 company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2019
Was the Report Sent to FDA? No
Date Manufacturer Received12/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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