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 12/17/2018

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).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #:(b)(4).Getinge usa sales, llc (b)(4).Contact peron: (b)(4).The investigation into this matter consists of an evaluation of the received device logs only as no parts have been reported as replaced.The received logs confirm the reported issue with high fico2 readings.A successful sco was performed prior to the event indicating that no technical malfunctions were present.Alarms for high fico2 level were generated during ongoing patient treatment.The logs show further that the co2 absorber was replaced during the case and that the user also tried to rectify the issue by increasing the fresh gas flow and activate the o2 flush several times without success.The received trend log confirms the high fio2 readings.We have not been able to determine the true cause of the reported issues.

Event Description

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

• Brand Name: FLOW-I C30
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 8178681
• MDR Text Key: 131138121
• Report Number: 8010042-2018-00680
• 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: 05/14/2019

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: 12/18/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 05/14/2019
• Supplement Dates FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1