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

Model Number R1113277

Device Problems Smoking (1585); Flare or Flash (2942)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an alice nightone device was sparking and smoking upon inserting the battery.The device was not in patient use at the time of the incident.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to the manufacturer for evaluation.Visual inspection found numerous physical issues with the returned device which included no battery compartment lid, no lower right-side end cap, no right-side hold-down screw, right-side belt area broken (bottom enclosure) and both sets of battery contacts bent and not in place.There was residue found on the outer battery's positive and negative contacts.The inner battery had slight blueish marks which could indicate a sparking incident.Additionally, the outer battery's contact area on the bottom enclosure was slightly melted which would indicate a thermal event.No internal damage was observed.The customer batteries were not returned for evaluation.Functional testing on the device was performed multiple times.No sparking or smoking occurred during the evaluation.However, due to the condition of the device when received, it was determined that the battery contact/battery connection issues were identified as the root cause of the reported issue.

• Brand Name: ALICE NIGHTONE
• Type of Device: 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 15208 ; 4125423300
• MDR Report Key: 17633788
• MDR Text Key: 322087387
• Report Number: 2518422-2023-20913
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Device Operator: Lay User/Patient
• Device Model Number: R1113277
• Device Catalogue Number: R1113277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1