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

Model Number	551BR
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Cancer (3262); Nodule (4551)
Date of Event	08/10/2021
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 became degraded and the patient developed a spot on her lung.The patient did require medical intervention in the form of prescribed medication.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.This action was reported to fda per 21 cfr part 806.The device will be corrected per res (b)(4).
Additional Manufacturer Narrative
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer previously received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and the patient developed a spot on her lung.The patient did require medical intervention in the form of prescribed medication.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 health effect - clinical code, health effect - impact code has been corrected, and type of investigation, investigation findings, and investigation conclusions have been updated.In the initial report, the section d4 unique identifier (udi) number was incorrectly added, which has been corrected / updated in this report.
Additional Manufacturer Narrative
Additional information was received on oct 29, 2024, and section h11 should be reported as: the manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devicesthe manufacturer received information alleging patient developed spot on her lung related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no report of serious patient harm or injury.The device was returned to the manufacturer's service center for further evaluation.The device was evaluated.The manufacturer concludes that they could confirm that there was visible foam degradation.There were four errors found.The manufacturer concludes that there was visible foam degradation.Sections b1, b2, h1 and h6 have been corrected in this report as follows: section b1 was corrected for only the product problem (both adverse events and product problem was checked in the previous mdr.) section b2 was corrected to blank.(previously, it was other serious or important medical events.) section h1 was changed from serious injury to malfunction.Section h6 health effects - impact code and device evaluation codes were updated.

• Brand Name: REMSTAR AUTO AFLEX ASSY, BR
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville; murrysville PA 15668
• Manufacturer Contact: rosko melissa ; 6501, living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12322694
• Report Number: 2518422-2021-03101
• Device Sequence Number: 17256826
• Product Code: BZD
• UDI-Device Identifier: 00606959023277
• UDI-Public: 00606959023277
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/15/2024

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: 551BR
• Device Catalogue Number: 551BR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 03/23/2023; 10/29/2024
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/13/2021; 08/30/2023; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2012
• 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: Female