MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR AUTO A-FLEX, SYSTEM ONE, 60 SERIES , GB; VENTILATOR, NON-CONTINUOUS (RESPIRATOR), PRODUCT CODE:BZD

Model Number GB561S

Device Problems Thermal Decomposition of Device (1071); Degraded (1153); Loose or Intermittent Connection (1371)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2019

Event Type  malfunction  

Event Description

The manufacturer received information that an end user alleged a thermal event had occurred to a power cord to a continuous positive airway pressure (cpap) device.It was not indicated where the damage had occurred, and there was no report of exposed wiring to ac components at that time.There was no harm or injury reported by the user.The manufacturer received the device and accessories for investigation and noted thermal damage to the ac inlet of the dc power supply and the ac power cord.The damage to the ac power cord connector resulted in an exposed terminal.There was no evidence of thermal damage to the cpap device.The thermal damage to the ac inlet of the dc power supply did not result in a void.The root cause of the event is most likely due to intermittent connection between the dc power supply inlet and the ac power cord.Product labeling warns the user to "periodically inspect the power for signs of wear and damage" and to "replace the power cord if necessary." there was no harm or injury reported.This device and accessories meet all relevant standards for flammability.Based on the available information, the manufacturer concludes no further action is necessary.

Manufacturer Narrative

This mdr is being submitted as part of a batch submission of previously closed complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.The manufacturer previously reported receiving information that an end user alleged a thermal event had occurred to a power cord to a continuous positive airway pressure (cpap) device.It was not indicated where the damage had occurred, and there was no report of exposed wiring to ac components at that time.There was no harm or injury reported by the user.The manufacturer received the device and accessories for investigation and noted thermal damage to the ac inlet of the dc power supply and the ac power cord.The damage to the ac power cord connector resulted in an exposed terminal.There was no evidence of thermal damage to the cpap device.The thermal damage to the ac inlet of the dc power supply did not result in a void.The root cause of the event is most likely due to intermittent connection between the dc power supply inlet and the ac power cord.During the evaluation of the device at the manufacturer's product investigation laboratory, an internal inspection of the restart revealed evidence of dirt/dust contaminants present in the blower assembly & sound abatement foam of the bottom enclosure.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

• Brand Name: REMSTAR AUTO A-FLEX, SYSTEM ONE, 60 SERIES , GB
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR), PRODUCT CODE:BZD
• 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: 9661392
• MDR Text Key: 177457355
• Report Number: 2518422-2020-00232
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030589
• UDI-Public: 00606959030589
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: GB561S
• Device Catalogue Number: GB561S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: FDA RES 88058
• Patient Sequence Number: 1
• Patient Sex: Male