ENDOME 433

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-11 for ENDOME 433 manufactured by Enraf Nonius.

Event Text Entries

[16147150] Patient felt an uncomfortable electrical charge when machine was initially turned on, but before controls were set. Service technician from company, that the hospital purchased the equipment from, evaluated machine and found no malfunction. He recommedned for future use that the machine be turned on before applying electrodes to patient to release any static build-up. Machine is being sent to distributor for further evaluationdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-sep-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, electrical tests performed. Results of evaluation: other. Conclusion: other. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service, device use continued with restrictions/limitations, user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2654
• MDR Report Key: 2654
• Date Received: 1993-01-11
• Date of Report: 1992-12-02
• Date of Event: 1992-11-19
• Date Facility Aware: 1992-11-19
• Report Date: 1992-12-02
• Date Reported to FDA: 1992-12-02
• Date Reported to Mfgr: 1992-11-20
• Date Added to Maude: 1993-03-23
• 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

• Generic Name: ELECTROTHERAPY EQUIPMENT
• Product Code: JXK
• Date Received: 1993-01-11
• Model Number: ENDOME 433
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-SEP-87
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2480
• Manufacturer: ENRAF NONIUS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-01-11