EXTENSION TABLE TOP 114020AN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for EXTENSION TABLE TOP 114020AN manufactured by Maquet Gmbh.

Event Text Entries

[174473704] At the time of this report the investigation is still ongoing. As soon as the investigation is finished the report will be updated and a follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10

[174473705] It was reported that a patient died. Further information concerning the course of the event and relation to the device was requested but not yet received. Manufacturer reference# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3013876692-2020-00004
• MDR Report Key: 9574270
• Date Received: 2020-01-10
• Date of Report: 2020-03-03
• Date of Event: 2020-01-02
• Date Facility Aware: 2020-03-03
• Report Date: 2020-03-03
• Date Reported to FDA: 2020-03-03
• Date Reported to Mfgr: 2020-03-03
• Date Mfgr Received: 2020-02-24
• Device Manufacturer Date: 2007-05-15
• Date Added to Maude: 2020-01-10
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EXTENSION TABLE TOP
• Generic Name: TABLE, OPERATING-ROOM, AC-POWERED
• Product Code: FQO
• Date Received: 2020-01-10
• Model Number: 114020AN
• Catalog Number: 114020AN
• Lot Number: N/A
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 151 MO
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MAQUET GMBH
• Manufacturer Address: KEHLER STRASSE 31 RASTATT US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death; 2. Other	2020-01-10