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

Model Number FLOW-C

Device Problem Output Problem (3005)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  malfunction  

Event Description

It was reported that the pressure tranducer test failed during system check out.There was no patient connected to the anesthesia workstation during the event.Manufacturer´s ref #: (b)(4).

Manufacturer Narrative

The anesthesia system was investigated on-site and it was found that one of the pressure transducer pcb's was faulty.It was replaced and returned for investigation.Our investigation of the returned inspiratory pressure transducer pcb found no visual deviations or damages on the pcb.Simulated use testing of the returned pcb reproduced the reported failure.The system checkout failed several tests due to the measured zero pressure offset for the inspiratory pressure transducer had drifted and exceeded the allowed limit (± 300 mv from factory default).Further test of the returned pcb concluded that the pressure sensor on the inspiratory pressure transducer pcb was broken.Evaluation of the received device logs confirmed the reported system check out failure.Our conclusion is that the reported failure was caused by a faulty pressure sensor on the inspiratory pressure transducer pcb.The pressure transducer pcb is part of the pressure measuring in the system.A faulty pressure transducer pcb may lead to inaccuracy in pressure measurement.This will be detected during system checkout and high priority alarms will be generated if the failure occurs during treatment.

Event Description

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

• Brand Name: FLOW-C
• 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: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 11358379
• MDR Text Key: 232894860
• Report Number: 8010042-2021-00447
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

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-C
• Device Catalogue Number: 6887700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2019
• 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