SUPPORT ARM 177 6481720

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-06-19 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.

Event Text Entries

[22141347] It was reported that the support arm broke. Pt info is unk. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

[22308630] Pt info was info surrounding the event has been sought. A supplemental medwatch will be submitted when the investigation has been completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 8010042-2014-00264
• MDR Report Key: 3964248
• Report Source: 01,07
• Date Received: 2014-06-19
• Date of Report: 2014-05-21
• Date Facility Aware: 2014-06-18
• Report Date: 2014-06-19
• Date Mfgr Received: 2014-05-21
• Date Added to Maude: 2014-08-06
• 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: 0
• Event Location: 3
• Manufacturer Contact: JANICE PEVIDE
• Manufacturer Street: 45 BARBOUR POND DRIVE
• Manufacturer City: WAYNE NJ 07470
• Manufacturer Country: US
• Manufacturer Postal: 07470
• Manufacturer Phone: 9737097753
• Manufacturer G1: MAQUET CRITICAL CARE AB
• Manufacturer City: SOLNA S-17154
• Manufacturer Country: SW
• Manufacturer Postal Code: S-17154
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SUPPORT ARM 177
• Product Code: IOY
• Date Received: 2014-06-19
• Catalog Number: 6481720
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MAQUET CRITICAL CARE AB
• Manufacturer Address: SOLNA SW

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-06-19