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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KOAXIALSCHLAUCHSYST. WT; BREATHING HOSE, DISPOSABLE
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KOAXIALSCHLAUCHSYST. WT; BREATHING HOSE, DISPOSABLE Back to Search Results
Catalog Number MP000373
Device Problems Gas Output Problem (1266); Obstruction of Flow (2423); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation was just started.The results will be provided in a follow-up report.
 
Event Description
It was reported that during the ongoing surgery, the patient could no longer be ventilated.After troubleshooting, it was found that the internal tubing of the coaxial system mp00373 was twisted and thus obstructed or prevented the flow of respiratory gas.The hose had been on the device since monday, (b)(6) 2021.No injury reported.
 
Manufacturer Narrative
For the investigation, the hose system in question was requested and provided.During the analysis at the manufacturer the described problem could be confirmed.It was found that the adhesive connection of the outer hose had come loose.This allowed the inner hose, which was firmly connected to the connector, to twist during use.An error during the bonding process in production was identified as the root cause.The adhesive is applied to the connector in a semicircle and distributed by circular movements when the hose is attached.Insufficient bonding of the hoses or a broken adhesive connection can result in reduced adhesion of the hose to the respective connector.This can additionally be favored by an insufficient amount of adhesive.The manufacturer has initiated additional training for employees regarding the bonding process and has ramped up visual inspection to 100% during packaging.The user is instructed in the instructions for use to inspect the breathing tube before use.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
 
Event Description
It was reported that during the ongoing surgery, the patient could no longer be ventilated.After troubleshooting, it was found that the internal tubing of the coaxial system mp00373 was twisted and thus obstructed or prevented the flow of respiratory gas.The hose had been on the device since monday, 04/19/21.No injury reported.
 
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Brand Name
KOAXIALSCHLAUCHSYST. WT
Type of Device
BREATHING HOSE, DISPOSABLE
MDR Report Key11788925
MDR Text Key252244075
Report Number9611500-2021-00199
Device Sequence Number1
Product Code BYE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMP000373
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/16/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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