MAUDE Adverse Event Report: RESPIRONICS INC DREAMSTATION AUTO CPAP, BL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	BLX500S15
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Cancer (3262); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop lung cancer.The patient did receive medical intervention in the form of a surgery for tumor removal.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.This action was reported to the fda per 21 cfr part 806.The device will be corrected per res 88058.Corrected data: d8 was this device serviced by a third party?: previously reported as no ; updated to unknown.E1 initial reporter contact / address / phone numbers.
Additional Manufacturer Narrative
The manufacturer previously received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop lung cancer.The patient did receive medical intervention in the form of a surgery for tumor removal.The previous report was filed as an adverse event.The manufacturer's clinical expert reviewed the event and determined there is no allegation of serious injury related to the device.In the initial report, section b5 was incorrect, the correct b5 should be- there was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection was completed by the manufacturer.The manufacturer found evidence of contamination in blower box, contamination on blower motor, contamination in iso port, water ingress in blower box, unknown mineral deposit.The manufacturer found no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found no error logged.The device was applied power and the device operated properly.The manufacturer concludes the contaminates found were consistent with contamination in blower box, contamination on blower motor, contamination in iso port, water ingress in blower box and an unknown mineral deposit was inconsistent with the sound abatement foam.The manufacturer confirmed there was no evidence of sound abatement foam degradation.Section b1,b2,b7,d8,d9,g3,h1,h6 has been updated/corrected.

• Brand Name: DREAMSTATION AUTO CPAP, BL
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15568
• 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: 12333162
• Report Number: 2518422-2021-03283
• Device Sequence Number: 14697747
• Product Code: BZD
• UDI-Device Identifier: 00606959027343
• UDI-Public: 00606959027343
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BLX500S15
• Device Catalogue Number: BLX500S15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 11/30/2022
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/16/2021; 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown