MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C20; GAS-MACHINE, ANESTHESIA

Model Number C20

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the anesthesia workstation failed the pressure transducer test during system check out.There was no patient involvement.(b)(4).

Event Description

Manufacturer ref #:(b)(4).

Manufacturer Narrative

The anesthesia workstation was investigated by our field service engineer.The inspiratory pressure transducer pcb, fresh gas pressure transducer and o2 fresh gas module were found faulty and was replaced.After this the system checkout passed without deviations.No parts were returned.Evaluation of the received device log confirm that the system checkout failed.The pressure transducer test failed due to the measured gain correction factor for the inspiratory pressure transducer being outside allowed limits.Also the flow transducer test, the manual ventilation leakage test and the vaporizer inlet/outlet valve test failed.The root cause of the reported system checkout failures cannot be determined as no parts were returned for investigation.However, based on that the system checkout passed without deviations after replacement of the above parts the conclusion is that these parts were faulty.

• Brand Name: FLOW-I C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 8478110
• MDR Text Key: 140886872
• Report Number: 8010042-2019-00236
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1