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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
Catalog Number 1053618
Device Problem Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Event Description
The customer requested philips to perform preventative maintenance (pm) and to check for a proximal line disconnection.The device was evaluated by an international philips field service engineer (fse).The fse was unable to confirm or duplicate the reported issue.The device malfunction was reported to have been discovered during clinical use.The patient was transferred to another working ventilator.There was no patient or user harm reported.The occurrence of "proximal pressure line disconnect" alarm was unable to be confirmed by the fse.A functional test on the items related to this alarm was performed but no abnormality was 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
MDR Report Key12420503
MDR Text Key270321885
Report Number2031642-2021-04758
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
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 Catalogue Number1053618
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date08/03/2021
Initial Date Manufacturer Received 08/03/2021
Initial Date FDA Received09/03/2021
Date Device Manufactured06/14/2011
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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