MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30

Catalog Number 6677300

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

It was reported that during a pre check a message absorber was prompted on the screen indicating that no co2 absorber was attached.The problem was caused by the pt cassette being dislocated.There was no pt harm reported.(b)(4).

Manufacturer Narrative

Further info and defective parts have been requested.A supplemental medwatch report will be provided when the investigation is finished.Refer to (b)(4).

• Brand Name: FLOW-I C30
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; solna 1715 4; SW 17154
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 4144342
• MDR Text Key: 20296657
• Report Number: 8010042-2014-00422
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: 133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2014,09/09/2014

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: 6677300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/17/2014
• Device Age: 21 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/09/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2012
• 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