MAUDE Adverse Event Report: AIRBEX NOMAD PRO2; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number 0.850.0021

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

The unit was returned, and an evaluation was completed.Upon initial investigation handset #1 was found to have some melting of the enclosure.This appears to be in the lower battery pack.No apparent heating of the upper battery pack was evident.The cell packs were removed from the enclosure.There is evidence that a short occurred in the lower battery pack between the cells and printed circuit board.It is not possible to determine the exact sequence of events that led to the thermal event.Thermal damage involved charring on the printed circuit board materials.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.However, it does look like a corrosive material was removing the solder mask on the printed circuit board.With the blue shrink wrap removed, the cells were detached from the battery pack circuit board assembly and the voltages measured: cell 1: 3.688vdc, cell 2: 0.155vdc, cell 3: 0.015vdc.Electrolyte leakage was apparent on the cell 2 pouch which is the middle cell of the pack.The cell was 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 cell pouch for inspection.The electrodes and separator within the cell were largely intact, indicating the cell did not undergo an internal thermal runaway event.This concludes the investigation.

Event Description

It was reported that the nomad x-ray system caught on fire.It was reported that the battery was left on the charger over the weekend and had caught fire.There was no report of user or patient injury or impact to patient care.The device was returned for evaluation.

• Brand Name: NOMAD PRO2
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): AIRBEX; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): AIRBEX; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: david waters ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877297
• MDR Report Key: 9071826
• MDR Text Key: 187512692
• Report Number: 1017522-2019-00015
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.850.0021
• Device Catalogue Number: FP 0150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• 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