MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PRO C-FLEX+; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	461CA
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2016
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.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
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 88058.Section b5 should have been reported as: a cpap was returned for service with an allegation of "service required, mask filled with smoke".The complaint also indicates the devices were making a "humming/shining sound".There was no patient harm or injury reported.The device was evaluated by the manufacturer and performed an external and internal inspection of the received device and found no evidence of thermal damages.There was evidence of dirt/dust contamination to the air inlet filters (air inlet path of the remstar) and also to the remstar sd card slot.This contamination was later found throughout the remstar air path.The blower assembly was disassemble and evidence of dirt/dust contamination and a dark-colored oil-like substance coating the internal surfaces of the remstar blower assembly was observed.The impeller assembly shows evidence of having fractured likely due to the impeller becoming unbalanced from the build-up of contaminants.The contaminants would also likely result in the degradation of the impeller assembly.There are indications of the impeller assembly having rubbed the blower assembly, likely resulting in the noted complaints.Based on the investigation, the manufacturer does confirm the complaints associated with the returned device.The complaints are found to be due to a failure of the blower impeller in the remstar as a result of improper care of the remstar by the user of the device and is not a result of a failure of the remstar during normal usage.The device was being used in an environment containing the dirt/dust contaminants and a dark-colored oil-like contaminants.These contaminants entered the remstar airpath leading to a failure of the remstar blower assembly.Section e.1 was incorrectly reported in previous report, which is now updated in this follow-up report.

• Brand Name: REMSTAR PRO C-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: 13830074
• Report Number: 2518422-2022-10995
• Device Sequence Number: 991419
• Product Code: BZD
• UDI-Device Identifier: 00606959030138
• UDI-Public: 00606959030138
• 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: 461CA
• Device Catalogue Number: 461CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: 11/22/2016
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2015
• 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