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

Model Number	BLX500H15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to develop black spots on the lung(s).The medical intervention that the patient received in response to the reported event is currently unknown.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 (b)(4).Corrected data: d8 was this device serviced by a third party?: previously reported as no ; updated to unknown.E1 initial reporter address.E4 initial reporter also sent report to fda?: previously reported as no ; updated to unknown.
Additional Manufacturer Narrative
The manufacturer was previously contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging a patient developed black spots on the lung(s).The medical intervention that the patient received in response to the reported event is currently unknown.The device is not returning to the manufacturer for evaluation.The manufacturer received information on (b)(6)2022 that the patient refuses to return the device.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: DREAMSTATION AUTO CPAP W/HUMID, BL
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 12341401
• Report Number: 2518422-2021-03367
• Device Sequence Number: 3736361
• Product Code: BZD
• UDI-Device Identifier: 00606959027350
• UDI-Public: 00606959027350
• 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): Unknown
• 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): 12/13/2022

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: BLX500H15
• Device Catalogue Number: BLX500H15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 08/04/2022
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/16/2021; 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HUMIDIFIER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown