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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 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
Device Problems Mechanical Problem (1384); Blocked Connection (2888)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/15/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported to philips an alarm for blower stopped turned on after the alarm for the patient circuit occluded alarm turned on.This event was reported to have occurred during patient use.No delay in therapy and no harm was reported.The patient was transferred to an alternative ventilator.The philips field service engineer (fse) performed a test run but the phenomenon was not duplicated.The event log revealed an occurrence of blower stalled (diagnostic code: 1134) had occurred.It was confirmed that the responded position was misaligned with the touched position, so calibration was performed but the phenomenon was not improved.The motor controller board and the touchscreen need replacing.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.
 
Manufacturer Narrative
H10: the customer elected to cancel the repair.The device was returned to the customer unrepaired.Based on information provided and/or service performed, the customers alleged malfunction was not confirmed.
 
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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
kimberly shelly
2271 cosmos court
carlsbad, CA 92011
7609187300
MDR Report Key15353793
MDR Text Key305381552
Report Number2031642-2022-02304
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838033832
UDI-Public00884838033832
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,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 Health Professional
Device Model NumberV60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
Device Catalogue Number1076709
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/15/2022
Initial Date FDA Received09/04/2022
Supplement Dates Manufacturer Received10/24/2022
Supplement Dates FDA Received10/26/2022
Date Device Manufactured01/07/2014
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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