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

Model Number	561CA
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Cough (4457); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2015
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to the cpap device's sound abatement foam.The patient alleged cough.There was no report of serious or permanent patient harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
This mdr is being submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.
Additional Manufacturer Narrative
The manufacturer previously reported incorrect information alleging an issue related to the cpap device's sound abatement foam.The patient alleged cough.There was no report of serious or permanent patient harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.Section b5 should have been reported as: a cpap was returned to the manufacturer for service due to an allegation of a black substance coming from the unit and the patient awaking with soot on their face.The patient alleged a cough.There was no serious harm or inury reported.The cpap was evaluated by the manufacturer and found no evidence of thermal damage or failure with the devices.Qa technician confirmed black soot residue on the inner nasal cushions portions of the resmed mask.The manufacterer operated the cpap for approximately 2.5 hour time period with a new bacteria filter installed on the outlet port of the remstar.An inspection of the filter after this time period found no evidence of black soot or any other contaminants.An internal inspection of the cpap surfaces was performed and there was no evidence of dirt/dust contamination.The manufacturer disassembled the blower assembly and found evidence of dirt/dust contamination on the impeller assembly.The contaminants would also likely result in the degradation of the impeller assembly which would likely result in the failure of the device.Based on the investigation performed, the manufacturer does confirm the complaints associated with the returned devices.The complaints are found to be a result of dirt/ dust entering though the fresh air intake and traveling throughout the devices air path as a result of improper care of the cpap by the user of the device and are not a result of a failure of the remstar during normal usage.Section e.1 and h.6 health effect - clinical code were incorrectly reported in previous report, which is now updated in this follow-up report.

• Brand Name: REMSTAR AUTO A-FLEX
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13878168
• Report Number: 2518422-2022-11036
• Device Sequence Number: 11941104
• Product Code: BZD
• UDI-Device Identifier: 00606959030527
• UDI-Public: 00606959030527
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

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 Number: 561CA
• Device Catalogue Number: 561CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2015
• Supplement Date Received by Manufacturer: 04/16/2015
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2013
• 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
• Patient Sex: Unknown