SCANNING TABLE UNKNOWN H25D3GG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-06-25 for SCANNING TABLE UNKNOWN H25D3GG manufactured by Adc Medical.

Event Text Entries

[2525] It was reported to ge that while a technician was moving a nuclear medicine scanning table, with a patient on it, a wheel came off of the table. The patient reportedly slid from the table to the floor and hit her head. She received a bruise and a small cut on her forehead. X-rays were taken of her skull and hip. A doctor examined her. No treatment was given for the cut on the forehead. It was also reported to ge that the patient died some 16 hours later. We have no information about the patient's pre-existing condition and our investigation has not produced any information about cause and effect. At this time we consider the fall and the subsequent death to be unrelateddevice 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: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2126677-1993-00005
• MDR Report Key: 5881
• Date Received: 1993-06-25
• Date of Report: 1993-05-13
• Date of Event: 1993-04-28
• Date Facility Aware: 1993-04-28
• Report Date: 1993-05-13
• Date Reported to FDA: 1993-05-13
• Date Reported to Mfgr: 1993-05-03
• Date Added to Maude: 1993-07-28
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• 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: SCANNING TABLE
• Generic Name: NUCLEAR MECHINE SCANNING TABLE
• Product Code: IYZ
• Date Received: 1993-06-25
• Model Number: UNKNOWN
• Catalog Number: H25D3GG
• Lot Number: UNKNOWN
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5579
• Manufacturer: ADC MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-06-25