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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLGER ULLRICH TABLE, OPERATING-ROOM, AC-POWERED

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HOLGER ULLRICH TABLE, OPERATING-ROOM, AC-POWERED Back to Search Results
Model Number 118001A0
Device Problem Inadequate User Interface (2958)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2018
Event Type  malfunction  
Manufacturer Narrative
At the time of this report the investigation was still ongoing.As soon as the investigation is finished the report will be updated and a follow up / final report will be provided to fda.(b)(4).
 
Event Description
During an ongoing surgery it was required to position the patient in trendelenburg position, however the column was not responding to the hand control.No injury has been reported.Medical intervention was needed as the patient's blood pressure needed to be corrected with intravenous treatment with more pharmaceutical treatment than necessary.(b)(4).
 
Manufacturer Narrative
Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france exemption # e2018005.(b)(4), contact person: (b)(6).The product in question is still in use at the clinic.We have been able to reproduce the behavior described by the customer with an identical product.If only one sensor detects a transporter, as is the case caused by a stool, then an error message is issued indicating that the transporter is not in the correct position.(incorrect transporter position).The procedure / adjustment of the system is not possible in this case.This behavior is intended because there is a risk of damage when using a transporter and moving the system at the same time.The table can only be transferred to the transporter in certain conditions.To trigger the sensor for the transporter detection, a metallic object must be placed directly in front of the sensor.If only one sensor is activated, an error message will show up as described above.The error message is accompanied by an acoustic signal.If the metallic object is removed from the sensor the system is fully functional again.No further actions are planned since there was no product failure and this is the first and only case such issue was reported to getinge-maquet.
 
Event Description
Manufacturer reference # (b)(4).
 
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Brand Name
TABLE, OPERATING-ROOM, AC-POWERED
Type of Device
TABLE, OPERATING-ROOM, AC-POWERED
Manufacturer (Section D)
HOLGER ULLRICH
maquet gmbh
kehler strasse 31,
rastatt 76437
GM  76437
MDR Report Key7898130
MDR Text Key121582463
Report Number8010652-2018-00022
Device Sequence Number1
Product Code FQO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 10/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number118001A0
Device Catalogue Number118001A0
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/23/2018
Initial Date FDA Received09/21/2018
Supplement Dates Manufacturer Received10/10/2018
Supplement Dates FDA Received10/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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