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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DREAMSTATION AUTO CPAP; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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DREAMSTATION AUTO CPAP; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number ESX500S15
Medical Device Problem Code Degraded (1153)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/17/2021
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no report of patient harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
 
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Brand Name
DREAMSTATION AUTO CPAP
Common Device Name
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
MDR Report Key12602234
Report Number2518422-2021-04377
Device Sequence Number4185707
Product Code MNT
UDI-Device Identifier00606959024274
UDI-Public00606959024274
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K131982
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 10/08/2021
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
Operator of Device Lay User/Patient
Device Model NumberESX500S15
Device Catalogue NumberESX500S15
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/17/2021
Initial Report FDA Received Date10/09/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured07/10/2019
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		RES 88058
Patient Sequence Number1
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