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

Catalog Number 6481720

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem Extubate (2402)

Event Date 10/28/2014

Event Type  Injury  

Event Description

It was reported tha a pt accidentally was extubated due to a self-lowering of the support arm, that holds the pt's circuit, at the level of joints.This incident lead to an emergency re-intubation, with difficult conditions.The rapid re-intubation was complicated by massive aspiration with hematosis degradation, requiring optimization of mechanical ventilation, sedation, curarization, and switching to ventral decubitus position (several sessions over 4/5 days).The final pt outcome was no injury.The support arm joints were tightened which solved the problem and the support arm was put back in use.(b)(4).Mfr ref # 8010042-2014-00549.

• Brand Name: SUPPORT ARM 177
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 4420294
• MDR Text Key: 5163543
• Report Number: 3008355164-2014-00303
• Device Sequence Number: 1
• Product Code: IOY
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization