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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

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RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number V60
Device Problems Calibration Problem (2890); Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/06/2021
Event Type  malfunction  
Manufacturer Narrative
Report date: 02sep2021.There was no patient involvement.
 
Event Description
It was reported to philips that the device had a 35-volt supply failure.The device was not in clinical use at the time of the event.There was no report of patient or user harm.
 
Manufacturer Narrative
B4:24sep2021.H11:b5: it was reported to philips that the device had a data acquisition printed circuit board assembly (da pcba) adc failure and a blower high temperature error.H10: a philips field service engineer (fse) was dispatched to the customer site.The reported issue was confirmed, and it was determined that the data acquisition printed circuit board assembly (da pcba) and motor control printed circuit board assembly (mc pcba) needed to be replaced to return the device to working condition.The fse replaced the da pcba and mc pcba to resolve the issue and bring the device back to functionality.Following the repair, the device was returned to the customer to be placed back into service.
 
Manufacturer Narrative
The data acquisition (da) pcba and motor controller (mc) pcba were returned for analysis.Visual inspection of all returned parts revealed no evidence of damage or contamination.A failure investigation (fi) was performed.The data acquisition (da) pcba and motor controller (mc) pcba were installed in the fi test ventilator in an attempt to duplicate the reported problem.The customer complaint was verified.The root cause is a failure of mc spi transmitter ic u10.
 
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Brand Name
RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, LLC
2271 cosmos court
carlsbad CA 92011
Manufacturer (Section G)
RESPIRONICS CALIFORNIA, LLC
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
melissa abbott
2271 cosmos court
carlsbad, CA 92011
7609187300
MDR Report Key12417878
MDR Text Key270326083
Report Number2031642-2021-04797
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838020054
UDI-Public00884838020054
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102985
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
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 Other
Device Model NumberV60
Device Catalogue Number1053617
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Distributor Facility Aware Date08/06/2021
Initial Date Manufacturer Received 08/06/2021
Initial Date FDA Received09/02/2021
Supplement Dates Manufacturer Received08/26/2021
02/17/2022
Supplement Dates FDA Received09/24/2021
03/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2021
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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