MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA

Model Number C30

Device Problems Vibration (1674); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the while in use on a patient, the anesthesia workstation generated noise, and vibrations were felt.Alarms for high pressure were generated.There was no patient harm reported.(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 person:(b)(4).The anesthesia workstation was investigated by our company field service engineer (fse).The nozzle units in the gas modules were replaced but was never returned.Therefore, no parts have been received for investigation.The investigation is based on the information given in the problem description and an evaluation of the received device logs.The problem description states that there were strange vibration and noise during operation.We have not received information stating at exactly what time the vibration and noise occurred.During the reported event day, no alarms for high or low o2 concentration or high or low agent concentration are present in the event log.Prior to the event day, several alarms for low fio2 were generated but there are no reports of vibrations and noise at that time.The measured parameter values in the trend log corresponds to the settings most of the time but during a time period of 15 minutes on the event day, irregularities in pressure, flow and volumes can be seen simultaneously as alarms such as etco2: low, leakage, respiratory rate: high, expiratory minute volume: low and airway pressure: high were generated.We have not been able to determine the true cause of the experienced event.

Event Description

Manufacturer's reference#:(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: 7961745
• MDR Text Key: 123676158
• Report Number: 8010042-2018-00533
• 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: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• 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
• Date Manufacturer Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1