MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SUPPORT ARM 177

Catalog Number 6481720

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the support arm broke.Pt info is unk.(b)(4).

Manufacturer Narrative

Pt info was info surrounding the event has been sought.A supplemental medwatch will be submitted when the investigation has been completed.(b)(4).

• Brand Name: SUPPORT ARM 177
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; solna S-17 154; SW S-17154
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3964248
• MDR Text Key: 22141347
• Report Number: 8010042-2014-00264
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/19/2014,05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6481720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/18/2014
• Event Location: Hospital
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1