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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 Blower (738); Infusion or Flow Problem (2964); No Pressure (2994)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Date of event: (b)(6) 2019. Date of report: 05dec2019.

 
Event Description

The customer reported pressure occlusion and a stalled blower. There was patient involvement, but no one was harmed. The manufacturer¿s field service engineer (fse) confirmed the reported issue. The fse checked the patient circuit, performed performance testing and checked the blower and software. The fse determined that the blower could not produce sufficient pressure or the blower speed signal had failed. The fse verified that the blower was connected to the mc pcba (motor controller printed circuit board assembly), verified that the blower rpm (revolutions per minute) monitor increased above 3000 rpm when the pressure controller was set to a value above 0 (cmh20) centimeters of water. The fse advised if the blower rpm did not increase above 3000 rpm to replace one of the following to re-establish the tachometer signal. The fse advised may be the blower, mc pcba, and/or (central processing unit). In reference to the patient circuit occlusion error, the fse checked the patient circuit for bulk liquid, crimps, or blocked filter. The fse confirmed the ventilator and alarm settings were appropriate. The fse advised if the problem persisted to provide alternative ventilation and to service the ventilator. The fse replaced the blower assembly and provided proper operation check. After corrective maintenance, the equipment is operational and complies with the manufacturer's specifications. The necessary checks have been carried out to certify the return to the pre-failure operating conditions.

 
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Brand NameV60 VENTILATOR
Type of DeviceVENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,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
melissa abbott
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key9418498
MDR Text Key179134666
Report Number2031642-2019-10755
Device Sequence Number1
Product Code MNT
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberK082660
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 11/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/05/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberV60
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 Received11/18/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/03/2010
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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