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

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2019

Event Type  malfunction  

Event Description

It was reported that while on a patient, a leakage from the co2 absorber of the anesthesia workstation was detected.There was no patient harm.Manufacturer's ref #: (b)(4).

Event Description

Manufacturer´s ref # : 226783.

Manufacturer Narrative

Background: based on the received complaint description stating that two similar events happened on two different anesthesia workstations at the same day, this additional complaint was created and was issued referens number (b)(4).The initial complaint was reported separate corresponding to mfg report number (b)(4).Investigation of returned parts: four co2 absorbers were returned for investigation but we have not been made aware to which one of the two events the co2 absorbers belong to.The performed investigation concluded that two of the returned absorbers had no damages and were found to be working as intended.One of the absorbers had a leakage at the bottom joint which added a small leakage during system check out (sco) but was still well inside the allowed limit.This leakage did not affect the ventilation.One of the absorbers was damaged at the bottom and a large piece of plastic was missing creating a large leakage leading to failure of multiple sub tests during sco.We have not been able to determine the cause of the damages and the leaking bottom joint.There are no reports of the package having been damaged during transportation.

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 8774644
• MDR Text Key: 150550358
• Report Number: 8010042-2019-00465
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1