MAUDE Adverse Event Report: RESPIRONICS, INC. ALICE NIGHTONE; VENTILATORY EFFORT RECORDER

Model Number	1114801
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was made aware of an allegation that a user received a burn injury to the chest while using the alice nightone device.Observations of powder coming out of the battery and peeling on the surface of the battery were reported.The patient was reportedly prescribed ointment for the burn and has not required any further intervention.The manufacturer has requested return of the device and all accessories that were in use at the time of the event, and the investigation is on-going.On completion of the manufacturer's investigation, a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer received the device for investigation.The original batteries that were used during the event were not returned with the device.There was no thermal damage noted to the battery compartment or to any internal pca components.Battery leakage was found during testing on the top side of the rf shielding.No overheating was noted.The batteries are not manufactured nor provided to the customer by the manufacturer of this device.Although a burn injury to a patient's chest was reported, the manufacturer concludes the device did not cause or contribute to the event.Based on the information available, the manufacturer also concludes no further action is necessary, but will continue to monitor the complaint system for similar events.

• Brand Name: ALICE NIGHTONE
• Common Device Name: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): RESPIRONICS, INC.; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: rod mell ; 6501 living place; pittsburgh, PA 15206 ; 7243349303
• MDR Report Key: 12668285
• Report Number: 2518422-2021-04601
• Device Sequence Number: 1206274
• Product Code: MNR
• UDI-Device Identifier: 00606959039797
• UDI-Public: 00606959039797
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2021

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: 1114801
• Device Catalogue Number: 1114801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2016
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male