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

Model Number C30

Device Problems Leak/Splash (1354); Tidal Volume Fluctuations (1634); Device Dislodged or Dislocated (2923)

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

Event Date 12/26/2014

Event Type  malfunction  

Event Description

It was reported that during patient treatment, the tidal volume decreased after replacing the co2 absorber.The patient cassette was found slightly dislodged from its original position and thus causing a leakage resulting in the reported tidal volume decrease.There was no patient harm reported.(b)(4).

Manufacturer Narrative

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

• Brand Name: FLOW-I C30
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer Contact: magnus lindqvist ; 2 roentgenvagen; solna 17154 ; SW 17154 ; 7307705
• MDR Report Key: 4403178
• MDR Text Key: 18068115
• Report Number: 8010042-2015-00005
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/26/2014

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 Model Number: C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/26/2014
• Initial Date FDA Received: 01/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1