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

Model Number	CNX700T17
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and a patient to develop cancer cells in the blood.The patient did receive medical intervention in the form of a comprehensive examination and lab testing.The investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
The manufacturer received information alleging a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and a patient to develop cancer cells in the blood.The patient did receive medical intervention in the form of a comprehensive examination and lab testing.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 issue related to sound abatement foam.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation related to the device's sound abate foam.This action was reported to fda per 21 cf1 part 806.The device will be corrected per res 88058.

• Brand Name: DREAMSTATION AUTO BIPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15568
• MDR Report Key: 12102993
• Report Number: 2518422-2021-02014
• Device Sequence Number: 4816275
• Product Code: BZD
• UDI-Device Identifier: 00606959042261
• UDI-Public: 00606959042261
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,other
• Initial Reporter Occupation: 505
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2021

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: CNX700T17
• Device Catalogue Number: CNX700T17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 08/16/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 09/07/2021; 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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