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

Model Number	557P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Sleep Dysfunction (2517)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop difficulty sleeping.The patient was prescribed medication in response to the reported event.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported this device on mdr 2518422-2021-05158-1.Please disregard mdr 2518422-2021-05158-1 as it was filed in error.
Additional Manufacturer Narrative
The manufacturer previously reported this device on mdr 2518422-2021-05158-1.Please disregard mdr 2518422-2021-05158-1 as it was filed in error.Previous report was filed incorrectly.Section h11 should be reported as: the manufacturer was contacted in reference to the voluntary field safety notice i recall notification related to the sound abatement foam in certain cpap.Bipap.And mechanical ventilator devices.The manufacturer previously reported an allegation of an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged visualization of particles.There was no refx) rt of serious or permanent harm or injury.The device was returned to the manufacturers service center for further evaluation the device was evaluated there was no mention of visual finding to the external part of the device the internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were 4 errors found.The manufacturer concludes that they could not confirm the customers allegation and there was no visible foam degradation.Section d8, d9, g3, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions) was corrected in this report.
Additional Manufacturer Narrative
Additional information was received on nov 12, 2024 and section h11 should be reported as the manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and patient alleged of difficulty sleeping.The patient was prescribed medication in response to the reported event.There was no report of patient harm or injury.The sections b1, b2, h1, h6 have been corrected in this report as follows: section b1 was corrected to product problem (adverse event and product problem was checked in the previous mdr).Section b2 was changed to blank (previously it was other serious).Section h1 was changed from serious injury to malfunction.Section h6 health effect - impact code was corrected.

• Brand Name: REMSTAR AUTO AFLEX
• Common Device Name: 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: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 12616743
• Report Number: 2518422-2021-05158
• Device Sequence Number: 3473802
• Product Code: BZD
• UDI-Device Identifier: 00606959039612
• UDI-Public: 00606959039612
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 557P
• Device Catalogue Number: 557P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: Not provided; 11/07/2023; Not provided
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 01/03/2025; 01/03/2025; 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2012
• 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 Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown