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

Model Number C30

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the anesthesia workstation generated alarms for high airway pressure during patient treatment.There was no patient harm.(b)(4).

Event Description

Manufacturer ref #: (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 peron:(b)(6).The anesthesia workstation was investigated on site and nozzle units from the o2, n2o and the air fresh gas modules as well as the nozzle unit from the reflector gas module were replaced and returned for investigation.The nozzle unit is part of the gas module that regulates the inspiratory oxygen gas flow to the patient.An evaluation of the logs confirm the reported event.The nozzle units were subjected to simulated use testing in a reference anesthesia workstation.The reported high pressure alarm was not reproduced, nor were any other alarms or faults found.Pm is performed every 5000 hours of operation or at least once a year.The nozzle unit has a predetermined lifetime and is replaced at the extended pm every second year (24 months interval).It is possible that the replaced nozzle unit contributed to the reported issue but without having been able to reproduce the reported issue, the true cause of the reported event cannot be determined.

• Brand Name: FLW-I C30
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 8353734
• MDR Text Key: 136740814
• Report Number: 8010042-2019-00099
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• 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: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1