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	Headache (1880); Epistaxis (4458)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The manufacturer received information alleging an issue related to the cpap device's sound abatement foam.The patient alleged headaches and nose bleeds.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
The manufacturer previously reported incorrect information alleging an issue related to the cpap device's sound abatement foam.The patient alleged headaches and nose bleeds.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 the device had a bad smell which created headaches and nose bleeds.There was no report of serious harm or injury.The device was returned to the manufacturer's product investigation laboratory (pil) and the customer's complaint was not duplicated.The pil did noticed that there was a chemical cleaner smell emanating from the devices.The pil operated the device for 2.5 hours and did not detect any harsh odors emitting from the device.The pil performed an internal inspection of the remstar/humidifier.As noted previously, pil observed a slight chemical/cleaner odor contaminant on the internal surfaces of the unit and on the sound abatement foam which is located on the inside bottom of the devices bottom enclosure where the fresh air enters the device.The manufacturer was not able to duplicate the reported complaint.Section e.1 was 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: 13846396
• Report Number: 2518422-2022-11004
• Device Sequence Number: 20016249
• Product Code: BZD
• UDI-Device Identifier: 00606959030527
• UDI-Public: 00606959030527
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/08/2022

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: 08/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 03/22/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2014
• 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