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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 Problem Defective Alarm (1014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 01aug2019.
 
Event Description
The customer reported that patient was on the device and was using the speaking mode and the speaking mode occlusion alarm kept alarming.The unit was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or the user.
 
Manufacturer Narrative
Date rec¿d by mfr : 24oct2019, date of report : 25oct2019.The manufacturer¿s technical services (ts) confirmed the reported issue.The clinical specialist spoke with the customer and answered questions regarding the speaking mode occlusion alarm.The customer was able to correct the alarm issue manually.The unit successfully passed the required performance verification test.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 patient was on the device and was using the speaking mode and the speaking mode occlusion alarm kept alarming.The unit was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or the user.
 
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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 Key8852763
MDR Text Key153225750
Report Number2031642-2019-05353
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 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV200
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER
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