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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number DSX520T11C
Device Problem Material Disintegration (1177)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2024
Event Type  malfunction  
Event Description
The manufacturer was contacted in reference to a ds2adv auto cpap device.The patient alleges shards of metal blowing out of the device.There was no allegation of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
Manufacturer Narrative
H3 other text : device not yet returned to the manufacturer.
 
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Brand Name
DS2ADV AUTO CPAP
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 Key18747809
MDR Text Key335964760
Report Number2518422-2024-08826
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200480
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDSX520T11C
Device Catalogue NumberDSX520T11C
Was Device Available for Evaluation? No
Date Manufacturer Received01/23/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/21/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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