MAUDE MDR 448

MDR report key
448
Report number
448
Event key
0
Event type
3
Date of event
1992-03-16
Date received
1992-04-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPECT SCANNING TABLENON CIRCULAR OBIT TABLESIEMENSIYZ820-826-276 REVISION AYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11992-04-2401. R

Event Narratives#

D

Patient 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.