SPECT SCANNING TABLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-04-24 for SPECT SCANNING TABLE manufactured by Siemens.

Event Text Entries

[17245743] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 448
• MDR Report Key: 448
• Date Received: 1992-04-24
• Date of Report: 1992-04-15
• Date of Event: 1992-03-16
• Date Facility Aware: 1992-03-16
• Report Date: 1992-04-15
• Date Reported to FDA: 1992-04-15
• Date Reported to Mfgr: 1992-04-14
• Date Added to Maude: 1992-04-29
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SPECT SCANNING TABLE
• Generic Name: NON CIRCULAR OBIT TABLE
• Product Code: IYZ
• Date Received: 1992-04-24
• Lot Number: 820-826-276 REVISION A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 442
• Manufacturer: SIEMENS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-04-24