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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 Problem Energy Output Problem (1431)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(6) 2020.Report date: 28dec2020.
 
Event Description
It was reported to philips that the device does not power on intermittently.The device was not being used on a patient at the time of the event.There was no patient or user harm reported.
 
Manufacturer Narrative
Device was evaluated by the customer and reported, " unit powers on intermittently and when does screen flickers and has horizontal lines." based on information provided by customer, remote service engineer advised about replacement of user interface (ui) assembly.Also provided customer with part identification (id) for ui assembly.Customer advised that he was going to swap ui assembly to see if resolves issue, but it did not.Then customer called back for part id for power management board and reported that issue was resolved with replacement of power management board.
 
Manufacturer Narrative
H11 (corrected data): upon further review of this record, it was determined that it is a duplicate of an event previously reported under mfr report #2031642-2020-02946.Any additional information will be submitted under the initially reported mfr report #2031642-2020-02946.
 
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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
carlsbad CA
Manufacturer Contact
kimberly shelly
2271 cosmos court
carlsbad, CA 92011
7609187300
MDR Report Key11041737
MDR Text Key222778050
Report Number2031642-2020-04640
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,Followup,Followup
Report Date 10/10/2022
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 Model NumberV60
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/23/2020
Initial Date FDA Received12/18/2020
Supplement Dates Manufacturer Received09/19/2022
10/06/2022
Supplement Dates FDA Received09/30/2022
10/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2009
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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