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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V680 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE PRODUCT CODE: CBK
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RESPIRONICS CALIFORNIA, INC V680 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE PRODUCT CODE: CBK Back to Search Results
Model Number V680
Device Problem Loss of Power (1475)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 29march2019.No phone number provided.A follow-up report will be submitted once the investigation has been completed.
 
Event Description
Customer contacted technical support ts) stating that unit turned off after a power fluctuation.The customer reported there was no patient involvement.Event date not specified; estimate used.
 
Event Description
Customer contacted technical support (ts) stating that unit turned off after a power fluctuation.The customer reported there was no patient involvement.Event date not specified; estimate used.
 
Manufacturer Narrative
Date rec'd from mfr: 16oct2019.This complaint has been inadvertently reported.The unit described is a v680 ventilator, which is not sold in the u.S.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
V680 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE PRODUCT CODE: CBK
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
MDR Report Key8466945
MDR Text Key140591505
Report Number2031642-2019-01915
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberV680
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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