MAUDE Adverse Event Report: RESPIRONICS INC. DREAMSTATION AUTO BIPAP/HUM/HT/CELL,CAN; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	CAX700T12C
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Easy Bruising (4558); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a bilevel positive airway pressure (bipap) device's sound abatement foam.There was no patient harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per (b)(4).
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 an issue related to a bipap device's sound abatement foam.The patient alleged visualization of particles.The patient also alleged having bothered eyes, cough, and headaches.There was no report of serious or permanent patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal and external visual inspection of device were completed by the manufacturer.The manufacturer found unknown white and black contamination (dust-like), inconsistent with degraded sound abatement foam, at the air input of the blower box, tiny unknown black (inconsistent with degraded sound abatement foam), brown and white specs of contamination on the bottom the blower box.The device's downloaded event log was reviewed by the manufacturer and found no error logged.The manufacturer confirmed there was no evidence of sound abatement foam degradation.The manufacturer also confirms there was no visible damage or functionality failures of the device, which suggest that the source of contamination was external to the device.

• Brand Name: DREAMSTATION AUTO BIPAP/HUM/HT/CELL,CAN
• 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: rod mell ; 1001 murry ridge lane; murrysville, PA 15668 ; 7249003460
• MDR Report Key: 12562329
• Report Number: 2518422-2021-04775
• Device Sequence Number: 19202092
• Product Code: BZD
• UDI-Device Identifier: 00606959034600
• UDI-Public: 00606959034600
• 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): 06/15/2023

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: CAX700T12C
• Device Catalogue Number: CAX700T12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2018
• 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
• Patient Sex: Unknown