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

Model Number FLOW-I C30

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2020

Event Type  malfunction  

Event Description

It was reported that during patient treatment, a technical error code indicating a power failure was generated.There was no patient harm.Manufacturer´s ref#: (b)(4).

Event Description

Manufacturer´s ref.# (b)(4).

Manufacturer Narrative

An investigation at the hospital concluded that the oxygen fresh gas module was defective and caused the reported technical error code.The oxygen fresh gas module was replaced by the distributor technician.After the replacement, the anesthesia system worked as intended and no technical error codes have been generated ever since.The replaced oxygen fresh gas module has not been available for investigation.The reported fault can be verified in the received logs which confirm that the oxygen fresh gas module was defective.The root cause of the fault in the oxygen fresh gas module has not been determined.H3 other text : 4114.

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 10599252
• MDR Text Key: 208934359
• Report Number: 8010042-2020-00699
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

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: FLOW-I C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1