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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 Problem Human-Device Interface Problem (2949)
Patient Problem Unspecified Respiratory Problem (4464)
Event Date 12/16/2021
Event Type  Injury  
Event Description
During clinical and therapeutic use of the v60 ventilator, the patient non-invasive interface became disconnected from the breathing circuit, resulting in subsequent need for patient intubation.The device was in clinical use providing therapy to the patient at the time of the event.Patient diagnosis, deidentified demographics, ventilator settings, circuit configuration, and interface were not disclosed by the reporter.The reported stated that due to the disconnection from the breathing circuit, the patient required intubation.Further patient outcome status was not disclosed.
 
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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 Key13079015
MDR Text Key282727010
Report Number2031642-2021-05866
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 Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberV60
Device Catalogue Number1053617
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/16/2021
Initial Date FDA Received12/23/2021
Date Device Manufactured01/08/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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