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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS CALIFORNIA, INC V200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number V200
Device Problems Erratic or Intermittent Display (1182); Loss of Power (1475)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 06may2019.A follow-up report will be submitted once the investigation has been complete.
 
Event Description
Customer contacted technical support (ts) stating that unit would transition to battery power intermittently.The customer reported there was no patient involvement.
 
Manufacturer Narrative
Date rec¿d by mfr : 13may2019, date of report : 08aug 2019.There was no on-site evaluation - this event was addressed in-house by the customer.The customer reported that the replacement of the power supply resolved this reported event.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
V200 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
MDR Report Key8584119
MDR Text Key144252198
Report Number2031642-2019-02815
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K102054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 04/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberV200
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/17/2019
Initial Date FDA Received05/06/2019
Supplement Dates Manufacturer Received04/17/2019
Supplement Dates FDA Received08/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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