4400 POWER PLUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for 4400 POWER PLUS manufactured by Birtcher Medical System.

Event Text Entries

[5289] During surgery, when keying unit and adjusting output, the esu will "hang up" appearing to still produce power. Reproduced problem in clinical engineering dept. And no power output was measured but the tone indicated that there was power output. No other units have experienced this problem. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding 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. Invalid data - regarding whether event presents imminent hazard. 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: 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: 9276
• MDR Report Key: 9276
• Date Received: 1994-07-29
• Date of Report: 1994-07-11
• Report Date: 1994-07-11
• Date Reported to Mfgr: 1994-04-09
• Date Added to Maude: 1994-12-07
• 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

• Brand Name: 4400 POWER PLUS
• Generic Name: ELECTROSURGICAL UNIT
• Product Code: FAR
• Date Received: 1994-07-29
• Model Number: 4400
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 8934
• Manufacturer: BIRTCHER MEDICAL SYSTEM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-07-29