MAUDE Adverse Event Report: AIRBEX NOMAD PRO; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number 0.850.0009

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

The reported handset and charging cradle were returned for evaluation.Upon visual inspection it appears that a thermal event occurred on the handset.It is not possible to determine the exact sequence of events that led to the thermal event.However, there is evidence that a short occurred in the upper battery pack between the cells and printed circuit board.The handset was separated from the charger.A visual inspection was performed, and the charger and handset were found to be corroded.Thermal damage involved charring on the printed circuit board materials, and damage to the printed circuit board is apparent with blistering and exposed copper traces.A trace to trace short cannot be eliminated as root cause for this thermal event.The root cause for the fault in the printed circuit board is unclear.The cells were detached from the battery pack circuit board assembly and the voltages measured; cell 4: 0.223vdc, cell 5: 0.021vdc and cell 6: 0.064vdc.All cells appear to have been involved in the thermal event, likely by supplying energy into a fault in the printed circuit board.Electrolyte leakage was apparent on cell 4, 5, and 6 pouches, and the cells are swollen which can lead to failure.It is not possible to determine if the electrolyte leakage contributed to the thermal event, or if the thermal event caused the leakage.The electrodes were removed from the cells 4, 5, and 6 pouches for inspection.The electrodes and separator within the cell were largely intact, indicating the cells did not undergo an internal thermal runaway event.This concludes the investigation.

Event Description

It was reported by the dealer sales representative that the nomad x-ray system handset melted while on the charging cradle.There was no report of user or patient injury or impact to patient care.The reported handset and charging cradle were returned for evaluation.

• Brand Name: NOMAD PRO
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): AIRBEX; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): ARIBEX; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: david waters ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877297
• MDR Report Key: 8941874
• MDR Text Key: 202515775
• Report Number: 1017522-2019-00012
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0.850.0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1