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

Model Number	FRX500S14
Health Effect - Clinical Codes	Toxicity (2333); No Patient Involvement (2645)
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was made aware that an end user alleged she was "poisoned" by using a continuous positive airway pressure (cpap) device.The end user reports being hospitalized.The date of the alleged event, date of admission, admitting diagnosis, treatment required, and length of stay are unknown at this time.A review of the device history records for the cpap and associated humidifier indicate they passed all testing and functioned as designed prior to leaving the manufacturing facility.A search of the manufacturer's complaint system indicates no similar reports of "poisoning" occurring with these devices.The manufacturer requested return of the devices for evaluation, and additional information.A follow up report will be filed upon completion of the manufacturer's investigation.
Additional Manufacturer Narrative
Additional information was received indicating that the end user now recants her allegation she was "poisoned" by the cpap device.There is no patient harm reported.The cpap and humidifier were evaluated by the manufacturer and they functioned as designed.The manufacturer concludes no further action is necessary.

• Brand Name: DREAMSTATION AUTO CPAP W/ A-FLEX
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 5983274
• Report Number: 2518422-2016-03995
• Device Sequence Number: 13473060
• Product Code: BZD
• UDI-Device Identifier: 00606959023574
• UDI-Public: 00606959023574
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2016

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: FRX500S14
• Device Catalogue Number: FRX500S14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 10/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DREAMSTATION HUMIDIFIER, PN FRXH, SN (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization