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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MODUTEC; TUBING, PRESSURE AND ACCESSORIES
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MODUTEC; TUBING, PRESSURE AND ACCESSORIES Back to Search Results
Model Number ARD517001955
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided upon results of investigation.Device not returned to manufacturer.
 
Event Description
On 3rd of may 2021 getinge became aware of an issue with one of our devices ¿ modutec.End covers were missing on the device.No injury has been reported due to mentioned issue however we decided to report it in abundance of caution as any parts transferred into sterile field might be a source of contamination.
 
Event Description
Manfuacturer's reference number (b)(4).
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
 
Manufacturer Narrative
Getinge became aware of an issue with one of our devices ¿ modutec.End covers were missing on the device.No injury has been reported due to mentioned issue however we decided to report it in abundance of caution as any parts transferred into sterile field might be a source of contamination.It was established that when the event occurred, the device did not meet its specification, due to end covers were missing on the device and it contributed to event.It was not established if in the time when the event occurred the device was or was not being used for the patient treatment.During the investigation, it was found that the reported scenario has never led, to date, to serious injury or worse.Manufacturer did not receive enough information to conduct the technical investigation.It is not possible to determine the part involved and the root cause.In case of new relevant information, the case will be reconsidered.When reviewing reportable events for this type of issues we were able to establish that the received incident is occurring at a very low ratio.It is the 2nd reported event -worldwide- relating to end covers were missing.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.
 
Event Description
Manufacturer's reference number (b)(4).
 
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Brand Name
MODUTEC
Type of Device
TUBING, PRESSURE AND ACCESSORIES
MDR Report Key11782426
MDR Text Key249255287
Report Number9710055-2021-00168
Device Sequence Number1
Product Code BYX
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,Followup
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberARD517001955
Device Catalogue NumberARD517001955
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/02/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/25/2008
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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