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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS INC REMSTAR AUTO AFLEX ASSY, CN; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESPIRONICS INC REMSTAR AUTO AFLEX ASSY, CN; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number 557P
Medical Device Problem Code Degraded (1153)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/03/2021
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
REMSTAR AUTO AFLEX ASSY, CN
Common Device Name
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESPIRONICS INC
1001 murry ridge lane
murrysville PA 15568
MDR Report Key12558514
Report Number2518422-2021-04536
Device Sequence Number17220216
Product Code BZD
UDI-Device Identifier00606959039612
UDI-Public00606959039612
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K091319
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 09/30/2021
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 Number557P
Device Catalogue Number557P
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/03/2021
Initial Report FDA Received Date09/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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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