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 02/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device and handset have been returned and forwarded to engineering for evaluation.Engineering evaluation has not been completed to date.Once the engineering evaluation has been completed a subsequent report will be submitted, detailing the results of the evaluation performed to include the results and conclusion codes.

Event Description

It was reported by the customer that the nomad x-ray system handset melted over the weekend.There was no report of user or patient injury or impact to patient care.The reported device and handset have been returned for evaluation.

Event Description

It was reported by the customer that the nomad x-ray system handset melted over the weekend.There was no report of user or patient injury or impact to patient care.The reported device and handset have been returned for evaluation.

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.A visual inspection of the handset indicated blackening on the top of the upper battery pack and its printed circuit board.Cells 6 appears to have been involved in the thermal event, likely by supplying energy into a fault in the board.Additionally there was a slight melting of the handset plastic enclosure.Visual inspection of the upper pack printed circuit board indicated thermal damage involving charring on the printed circuit board materials, damage to the printed circuit board is apparent with blistering and exposed copper traces and a trace to trace short cannot be eliminated as root cause for this thermal event.The root cause for the fault in the board is unclear.Visual inspection of the upper pack cells with the blue shrink wrap removed, the cells were detached from the battery pack circuit board assembly and the voltages measured: cell 4: 177mv, cell 5: 176mv and cell 6: 0.039mv.Cells 6 appears to have been involved in the thermal event, likely by supplying energy into a fault in the board.Visual inspection of the upper pack cells on the opposite side indicated electrolyte leakage was apparent on the cells, 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.This concludes the investigation.

• Brand Name: NOMAD PRO
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): AIRBEX; 11727 fruehauf drive; charlotte, nc
• MDR Report Key: 9820640
• MDR Text Key: 196103433
• Report Number: 1017522-2020-00003
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• PMA/PMN Number: K081664
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.850.0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1