MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA

Model Number C30

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the anesthesia workstation measured a higher fico2 level than expected during an extended time period.There was no patient harm.(b)(4).

Event Description

Manufacturer's ref #: (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #: e2018003.Getinge usa sales, llc 45 barbour pond drive wayne, nj 07470.Contact peron: (b)(4).The anesthesia workstation was examined by the hospital technicians without being able to reproduce the issues.No information has been provided whether any parts have been replaced or if the reported issue has recurred since.Device logs have been received and the reported issue with a high fico2 level despite having changed the co2 absorber can be confirmed.The clinical alarms that were generated show that high fico2 values were measured but without having received any additional information surrounding the event such as replaced parts, we cannot determine the cause of the reported increased level of fico2 values.

• Brand Name: FLOW-I C30
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 8185545
• MDR Text Key: 131309615
• Report Number: 8010042-2018-00692
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1