113001D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for 113001D manufactured by Siemens Medical.

Event Text Entries

[2948] Or table placed in trandelberg position. The bed continued to go into a steeper trendelberg position even when the controls were not touched. The operator had to be repeatedly bring the table into the proper positioninvalid 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: user facility biomedical/bioengineering department. 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, mechanical tests performed, visual examination. Results of evaluation: other. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4725
• MDR Report Key: 4725
• Date Received: 1992-07-31
• Date of Report: 1992-05-06
• Date of Event: 1992-04-07
• Date Facility Aware: 1992-04-07
• Report Date: 1992-05-06
• Date Reported to Mfgr: 1992-05-06
• Date Added to Maude: 1993-06-07
• 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

• Product Code: FNK
• Date Received: 1992-07-31
• Model Number: 113001D
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4441
• Manufacturer: SIEMENS MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-31