MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that before patient treatment, when a co2 absorber was installed, one of the two co2 absorber valves became dislocated from its original position.This resulted in a leakage.After the co2 absorber valve had been repositioned, the unit worked as intended again.There was no patient connected to the anesthesia workstation at the time of the event.(b)(4).

Manufacturer Narrative

A supplemental medwatch report will be provided when the investigation is finished.(b)(4).

• Brand Name: FLOW-I
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer Contact: magnus lindqvist ; 2 roentgenvagen; solna 17154 ; SW 17154 ; 730770
• MDR Report Key: 4403131
• MDR Text Key: 21548676
• Report Number: 8010042-2015-00003
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/07/2015
• 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