MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AUTO SERIES ASSY; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	750P
Medical Device Problem Codes	Degraded (1153); Device Emits Odor (1425); Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2012
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 a bipap device's sound abatement foam.During device evaluation, foam degradation was observed in the device blower resulting in blower box replacement.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 an incorrect information in section b5.After review it was determined that there no foam degardation identified during the evaluation.The correct information on section b5, d9 and g3 has been updated in this report.Section b5 should becorrected/reported as: the manufacturer previously received an information from the user of bipap auto series alleging device caused thermal event such as sparking, smoking and electrical burning smell.The user stated there was no visible flame and seeing smoke from device.The user also noticed the loss of pressure before the thermal incident and the device has black/white residue in the window.There was no report of harm or serious injury.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacture inspected internally observed that evidence of thermal event occured in circuit board and thermal damage in humidifier interface connector.The smoke deposits on the internal surface of the top enclosure and window due to the thermal event.The manufacturer concludes there was an evidence of thermal event such as burning, smoking in device due to the thermal failure of humidifier interface connector and there is no other evidence of thermal damage in the device.The device was scarpped.Section h6 type of investigation, investigation findings and investigation conclusions has been updated.Section d9 and g3 has been corrected in this report.

• Brand Name: BIPAP AUTO SERIES ASSY
• 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: 13741362
• Report Number: 2518422-2022-08532
• Device Sequence Number: 4951227
• Product Code: BZD
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K 131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2023

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: 750P
• Device Catalogue Number: 750P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2012
• Supplement Date Received by Manufacturer: 11/11/2022; 11/19/2012
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 07/14/2023; 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2010
• 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