The customer reported the procedure headlight sparked while the user was wearing the device.The procedure headlight was plugged into a battery pack when visible sparks were noted on the outside of the device.There was no injury or burn to the user or patient.This headlight is designed to meet the various needs of the physician¿s office, hospital environment, and specialist¿s office.Although this event did not result in injury to the user or patient, the reported malfunction of the headlight sparking while in use could contribute to a serious injury or death if it were to recur.Additionally, if the reported event were to occur in an oxygen rich environment, the risk of ignition and fire significantly increases.The ifu does however state a warning green series procedure headlight is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide.An explosion may result.Therefore, hillrom considers this complaint a reportable malfunction.Based on this information, no further action is required.
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