VISUCAM PRO NM 2

Additional Manufacturer Narrative

THE DEVICE WAS REQUESTED TO BE SENT TO THE MANUFACTURER FOR FURTHER EVALUATION. THE DEVICE WAS PICKED UP FROM THE CUSTOMER SITE, HOWEVER, IT WAS LOST IN TRANSIT. THEREFORE, NO DEVICE TESTING COULD BE PERFORMED BY THE MANUFACTURER. A DEFINITE ROOT CASE COULD NOT BE IDENTIFIED SINCE THE DEVICE COULD NOT BE EVALUATED. THE COMPLAINT DATA ANALYSIS INDICATES THAT THE ISSUE IS NOT SYSTEMIC, AND THE LABELING WAS FOUND TO BE ADEQUATE. THE DEVICE WAS REMOVED FROM THE CUSTOMER'S SITE AND NO FURTHER ACTION WILL BE TAKEN. DESCRIPTIONS OF CHANGES: FIELD D9: UPDATED TO "NO". FIELD G1-2: UPDATED TO "(B)(6). FIELD G6: UPDATED TO "FOLLOW-UP #: 1". FIELD H2: ENTERED "ADDITIONAL INFORMATION". FIELD H3: UPDATED "IF NOT EVALUATED, SELECT AN EXPLANATION AS TO WHY NOT" TO "OTHER (CODE UNSPECIFIED, DESCRIBE IN H10)". FIELD H6: UPDATED INVESTIGATION FINDINGS CODE TO "3221". UPDATED INVESTIGATION CONCLUSIONS CODE TO "4315" FIELD H10: ADDED ADDITIONAL MANUFACTURER NARRATIVE AND DESCRIPTIONS OF CHANGES.

Description of Event or Problem

IT WAS REPORTED THAT A TECHNICIAN RECEIVED AN ELECTRIC SHOCK WHEN SHE TOUCHED THE SWITCH OF THE POWER BUTTON OF THE VISUCAM PRO NM 2. THE TECHNICIAN WAS NOT INJURED FROM THE EVENT. SHE DID NOT CONSULT A PHYSICIAN NOR DID SHE REQUIRE ANY MEDICAL TREATMENT.