AMSCOMATIC WASHER/STERILIZER E84WS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-13 for AMSCOMATIC WASHER/STERILIZER E84WS manufactured by Amsco/service Company.

Event Text Entries

[16758870] On 3/9/92, an employee in the central service department injured her left index finger and sustained a second and third degree burns to her hands. A basket became caught and the employee stuck her hand in the machine and the door closed on her hand. Our investigation revealed employee error as the cause of this incidentinvalid 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. 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: 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: 3903
• MDR Report Key: 3903
• Date Received: 1992-07-13
• Date of Report: 1992-07-01
• Date of Event: 1992-03-09
• Report Date: 1992-07-01
• Date Added to Maude: 1993-05-07
• 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: AMSCOMATIC WASHER/STERILIZER
• Product Code: ECG
• Date Received: 1992-07-13
• Model Number: E84WS
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 3643
• Manufacturer: AMSCO/SERVICE COMPANY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-13