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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 Premature Discharge of Battery (1057); Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The customer did not approve the quote for repair. There were no parts replaced.
 
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer reported the backup battery is not available. The fse clarified the backup battery is depleted, is unable to be charged or maintain a charge. The customer reported there was no patient involvement.
 
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Brand NameV200 VENTILATOR
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
richa shah
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6582751
MDR Text Key108764236
Report Number2031642-2017-01711
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K102054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberV200
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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