SUPPORT ARM 6481720 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,08 report with the FDA on 2006-07-14 for SUPPORT ARM 6481720 * manufactured by Maquet Critical Care Ab.

Event Text Entries

[15032370] When in use with a patient, the support arm 177 was suddenly broken, and the holder and patient tubes fell on the patient. No serious injury was caused.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8010042-2006-00056
• MDR Report Key: 738163
• Report Source: 06,07,08
• Date Received: 2006-07-14
• Date of Report: 2006-06-26
• Date of Event: 2006-06-23
• Date Facility Aware: 2006-07-07
• Report Date: 2006-06-26
• Date Reported to Mfgr: 2006-06-27
• Date Added to Maude: 2006-07-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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
• Manufacturer Contact: JAMIE YIEH
• Manufacturer Street: SUITE 202
• Manufacturer City: BRIDGEWATER NJ 08807
• Manufacturer Country: US
• Manufacturer Postal: 08807
• Manufacturer Phone: 9089472311
• Manufacturer G1: MAQUET CRITICAL CARE AB
• Manufacturer Street: *
• Manufacturer City: SOLNA S-171 95
• Manufacturer Country: SW
• Manufacturer Postal Code: S-171 95
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SUPPORT ARM
• Generic Name: *
• Product Code: ITY
• Date Received: 2006-07-14
• Model Number: 6481720
• Catalog Number: *
• Lot Number: NA
• ID Number: *
• Device Availability: *
• Device Age: NO INFO
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: U
• Device Sequence No: 1
• Device Event Key: 726044
• Manufacturer: MAQUET CRITICAL CARE AB
• Manufacturer Address: * * SW

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-07-14