MAUDE Adverse Event Report: RESPIRONICS, INC.. ALICE NIGHTONE N.A. WIRELESS W/ NONIN; VENTILATORY EFFORT RECORDER

Model Number	1133948
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation of the battery cover on the alice nightone had melted and the battery coil inside the device looked burnt and melted.This event occurred recording a patient study while in use.There was no smoke, flame or voids to the outer casing.There was no patient harm or injury reported.The device has not yet been returned to the manufacturer.The manufacturer's investigation is on-going.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer became aware of an allegation of the battery cover on the alice nightone had melted and the battery coil inside the device looked burnt and melted.This event occurred during the recording of a patient study while in use.There was no smoke, flame or voids to the outer casing.There was no patient harm or injury reported.The device was received by the manufacturer.The technician confirms the complaint of "battery cover melted to the coil".The lab investigation could not confirm the root cause for the complaint.Visual inspection found the upper battery's + terminal melted into the adjacent bottom case plastic.No damage to the battery compartment cover was observed.The customer batteries used during the study were not sent in for investigation.Other than the battery contact being melted into the bottom enclosure, no other external or internal signs of thermal damage were observed.In order for testing to be performed, a new battery contact and belt spring pin connector were installed on the main pca board.The unit was configured to the pc and then functionally tested for 28 minutes with lab supplied batteries.During the testing the ano spo2 and pflow lights would not turn green.After the device was downloaded, only signals from the effort belt were recorded.Temperature readings taken from the top cover were within normal limits.No battery smoking or melting was observed.It was found that on the main pca , component u3 was damaged.U3 is in the pflow circuit.The display board and the spo2 module were replaced.Another test study was performed, but signals did not return.Temperatures were consistant during all repeat studies.The spo2 and pflow parameters of the ano were not functioning.The manufacturer could not duplicate the thermal event to the battery coils.This is a follow up final report.The manufacturer concludes no further action is needed at this time.

• Brand Name: ALICE NIGHTONE N.A. WIRELESS W/ NONIN
• Common Device Name: VENTILATORY EFFORT RECORDER
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13235120
• Report Number: 2518422-2022-00668
• Device Sequence Number: 4280198
• Product Code: MNR
• UDI-Device Identifier: 00606959047341
• UDI-Public: 00606959047341
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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: 1133948
• Device Catalogue Number: 1133948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown