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

Model Number 1113277

Device Problem Battery Problem (2885)

Patient Problem Burn(s) (1757)

Event Date 05/26/2020

Event Type  Injury  

Event Description

The manufacturer was made aware of an allegation by a patient that he received a burn injury to his chest while using the alice nightone device.The reporter indicated the batteries leaked while the device was in use.The patient was reportedly prescribed antibiotics 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.

Manufacturer Narrative

The manufacturer received the device for investigation.The device was not operational.There was no thermal damage noted to the battery compartment or any internal pca components.There was damage noted to the aa batteries that were reportedly in use, with evidence of bulging and leaking.The batteries are not manufactured or 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
• Type of Device: VENTILATORY EFFORT RECORDER
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville, pa
• MDR Report Key: 10164610
• MDR Text Key: 195470767
• Report Number: 2518422-2020-01320
• Device Sequence Number: 1
• Product Code: MNR
• Combination Product (y/n): N
• PMA/PMN Number: K083874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: 1113277
• Device Catalogue Number: 1113277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other