* 1403 ACT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-01-28 for * 1403 ACT manufactured by Industrial Acoustics Co.

Event Text Entries

[20137962] Door latch broke, with door closed. Door hinges being stainless and massive took approx one hour to cut through. Employee was trapped inside booth for one hour. Door has no emergency release.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 211903
• MDR Report Key: 211903
• Date Received: 1999-01-28
• Date of Report: 1999-01-28
• Date of Event: 1999-01-27
• Date Facility Aware: 1999-01-27
• Date Reported to FDA: 1999-01-29
• Date Reported to Mfgr: 1999-01-29
• Date Added to Maude: 1999-03-03
• 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
• Reporter Occupation: BIOMEDICAL ENGINEER
• 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: *
• Generic Name: AUDIOMETRIC SOUND SUITE
• Product Code: EWC
• Date Received: 1999-01-28
• Model Number: *
• Catalog Number: 1403 ACT
• Lot Number: *
• ID Number: EQUIP ID# 603 EE 15644
• Device Availability: *
• Device Age: 1 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 205642
• Manufacturer: INDUSTRIAL ACOUSTICS CO
• Manufacturer Address: 1160 COMMERCE AVE BRONX NY 10462 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-01-28