FDA Adverse Event Injury Summary report: N

SPECT SCANNING TABLE

MDR report key: 448 · Received April 24, 1992

Report

Report Number
448
Event Type
Injury
Date Received
April 24, 1992
Date of Event
March 16, 1992
Report Date
April 15, 1992
Manufacturer
SIEMENS
Product Code
IYZ
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

PATIENT WAS A 76 YEAR OLD MALE WITH ASHD WHO WAS IN NUCLEAR MEDICINE FOR A MYO PERFUSION EXERCISE, ON AN OUTPATIENT BASIS. HE WAS LYING ON HIS BACK ON THE SPECT TABLE. THE TECH INFORMED HIM HE NEEDED TO TURN ONTO HIS STOMACH TO OBTAIN ADDITIONAL PHOTOS. AS THE PATIENT BEGAN TO TURN, THE TECH WAS HOLDING AND GUIDING HIM OVER. THE PATIENT SHIFTED HIS WEIGHT BACK WHICH CAUSED HIM TO FALL OFF THE TABLE, LANDING ON HIS RIGHT SIDE. THE TABLE WAS 44 INCHES OFF THE FLOOR AT THE TIME THE PATIENT FELL. THE PATIENT SUSTAINED MULTIPLE RIB FRACTURES, RIGHT CLAVICLE FRACTURE AND A HEMO PNEUMO THORAX. HE WAS SUBSEQUENTLY HOSPITALIZED FOR FURTHER TREATMENTDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: MANUFACTURER. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SPECT SCANNING TABLE Implant NON CIRCULAR OBIT TABLE IYZ SIEMENS 820-826-276 REVISION A

Patients

Seq Age Sex Outcome Treatment
1 78 YR Required Intervention