FDA Adverse Event Injury Summary report: N

X-RAY IMAGE INTENSIFIER

MDR report key: 2730 · Received July 2, 1992

Report

Report Number
2730
Event Type
Injury
Date Received
July 2, 1992
Date of Event
May 27, 1992
Report Date
June 8, 1992
Manufacturer
TOSHIBA
Product Code
JAA
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

THIS 25 YEAR OLD MALE WAS AT THE ONCOLOGY CENTER, HE RECEIVED AN ELECTRICAL SHOCK WHILE JIGGLING AN ELECTRICAL PLUG. HE DIDN'T KNOW IF THERE WAS AN ARC, HE HAD HIS HEAD TURNED WHILE TALKING TO A PATIENT. HE IS COMPLAINING OF A LITTLE TINGLING IN HIS LEFT RADIATING UP INTO HIS LEFT ARM AND SHOULDER. HE IS FEELING SHAKY. HE WAS NOT KNOCKED OUT BUT HE WAS THROWN BACK ABOUT 5'INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAR-92. SERVICE PROVIDED BY: INDEPENDENT SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 X-RAY IMAGE INTENSIFIER N/I JAA TOSHIBA LX-30A

Patients

Seq Age Sex Outcome Treatment
1 25 YR Required Intervention