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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 Energy Output Problem (1431); Failure to Power Up (1476)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 04aug2020.
 
Event Description
It was reported to philips by the customer (biomed) that the main power light is amber, indicating ac power, but every 30 seconds the power led turns green then beeps and goes back to amber.The customer stated the device will not power on with ac power only.The customer confirmed that the power supply has the 12 and 24 volts.The device was not in clinical use at the time of the event and there was no report of patient or user harm.A philips field service engineer (fse) was dispatched to the customer site.The fse tried to power the device on, checked voltages at power supply, unplugged from ac, and the device still would not power on.The fse then disconnected the battery and the reported issue was confirmed and traced the issue to a faulty power management pcba (printed circuit board assembly).The fse replaced the power management pcba and the device powered on and passed performance assurance testing.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, 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 Key10364819
MDR Text Key202727469
Report Number2031642-2020-02659
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/15/2020
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 No Information
Device Model NumberV60
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/15/2020
Initial Date FDA Received08/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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