MAUDE Adverse Event Report: ARIBEX NOMAD DENTAL 60KV; EXTRAORAL SOURCE X-RAY SYSTEM

Model Number 0.850.0000

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

The unit was returned to the manufacture and an evaluation was conducted.Upon initial evaluation, it was determined that the reported complaint of caught on fire could not be confirmed.Visual inspection showed the battery terminals inside the unit and one battery were blackened.Also, the cap was missing, and the device could have been dropped.Further examination revealed that the battery terminals were shorted.It appears that the contacts of the battery terminal became weak over time, from repeated battery insertion.This caused the negative and positive battery terminals to touch, causing a short.Also, the plastic enclosure was found to be blackened.Due to the protection circuitry in the battery and the tube head, it is not possible that the battery would become hot, cause an external fire or melt.It was then determined that the event was not reportable.Upon receiving further information from the dental office, an additional evaluation was conducted.Upon visual inspection, the device appeared to shows signs of damage related to being dropped several times.It also appears that the device has been used extensively.Visual inspection also showed that the battery terminals inside the device and one battery was overheated.Analysis of the battery contacts showed that they shorted together causing a large surge of energy to dissipate there when a battery was inserted.This caused the blackening of the pcb and of the battery.The battery became hot as shown by the blistering of the lower housing.There is evidence of heat damage, possibly due to fire.It is unknown if the contacts became shorted because of the unit being dropped or if they weakened over time from repeated use.The shorting of the contacts caused the negative and positive battery terminals to touch, causing a short.This was the occurrence that lead to the thermal event.The device will not be repaired and is subject to being discarded.This completes the investigation.

Event Description

It was reported by a dealer sales representative that the nomad x-ray system caught fire.There was no report of user or patient injury or impact to patient care.Additional information of the event was obtained from the dental office after the initial report was made.The dental office stated that the unit was being used for patients and had been set down between patients.The dental assistant then noticed the unit battery started to smoke.Using a paper towel, the battery was removed and instantly caught on fire at the top of the battery.The battery was dropped and the fire extinguished instantly.The battery was extremely warm.There was no report of injuries and no reported property damage.

• Brand Name: NOMAD DENTAL 60KV
• Type of Device: EXTRAORAL SOURCE X-RAY SYSTEM
• Manufacturer (Section D): ARIBEX; 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: 8726362
• MDR Text Key: 151116101
• Report Number: 1017522-2019-00011
• Device Sequence Number: 1
• Product Code: EHD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0.850.0000
• Device Catalogue Number: FP 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2012
• 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