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

Model Number FLOW-C

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2021

Event Type  malfunction  

Event Description

It was reported that the anesthesia workstation failed the pressure transducer test during system checkout.There was no patient involvement.Manufacturer's reference #: (b)(4).

Manufacturer Narrative

The anesthesia system was investigated on-site and it was found that the inspiratory pressure transducer pcb was faulty.It was replaced and returned for investigation.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 check out failed in 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 root cause of the pressure sensor failure has not been determined.

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
• MDR Report Key: 11320140
• MDR Text Key: 231573125
• Report Number: 8010042-2021-00356
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K191027
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1