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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2014
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.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.
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.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 (b.Section b5 should have been reported as: a cpap was returned for service with an allegation that the unit would no power on.There was no patient harm or injury reported.The device was evaluated by the manufacturer and a visual inspection of the remstar found evidence of dark-colored liquid contaminant on the top enclosure.Removal of the top enclosure overlay also found evidence of similar contaminants.The internal inspection of the remstar found evidence of a thermal failure to pca components (display side) j2, c29, u1, cr2, q8, and components proximal to these components.Additionally, there is evidence of thermal damage found to the non-display side of the pca.There is evidence of a dark-colored liquid on the pca (similar to that noted previously).The reported event is a result of the remstar pca being exposed to an unknown dark-colored liquid contaminant.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: 13878146
• Report Number: 2518422-2022-11023
• Device Sequence Number: 17316420
• 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): 09/09/2022

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: 07/18/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2014
• Supplement Date Received by Manufacturer: 07/21/2014
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2013
• 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