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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR AUTO A-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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RESPIRONICS, INC. REMSTAR AUTO A-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number DE562S
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2023
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
 
Event Description
A device was returned to a third party service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the evaluation of the device at the third party service center, the device was visually inspected and found a burnt humidifier base cable.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
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Brand Name
REMSTAR AUTO A-FLEX
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
kimberly shelly
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key18271771
MDR Text Key329779190
Report Number2518422-2023-33597
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K131982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
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 Lay User/Patient
Device Model NumberDE562S
Device Catalogue NumberDE562S
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/23/2023
Initial Date FDA Received12/05/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/18/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1974-2021
Patient Sequence Number1
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