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

Catalog Number 6481720

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

It was reported that the support arm broke.There was no patient harm.Importer reference #: (b)(4).

Manufacturer Narrative

Further information surrounding the event has been sought.A supplemental medwatch will be submitted when the investigation is completed.Reference exemption #:(b)(4).

• Brand Name: SUPORT 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 dr.; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3979223
• MDR Text Key: 17385293
• Report Number: 8010042-2014-00316
• Device Sequence Number: 1
• Product Code: IOY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2014,06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2014
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1