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

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).

• 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 Key: 7898130
• MDR Text Key: 121582463
• Report Number: 8010652-2018-00022
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• 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: 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 Number: 118001A0
• Device Catalogue Number: 118001A0
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 10/10/2018
• Supplement Dates FDA Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention