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

Catalog Number 113211A2

Device Problems Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

At the time of this report the investigation is 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

The following incident was reported.The patient was on the table and intubated for a shoulder surgery in supine position.The patient should be positioned in a mid-sitting position.The remote control has not functioned.In the meantime the table is said to have moved on its own to a trendelenburg position.The movement could not be stopped by the operator.It was not possible to stop this movement by using the emergency control panel on the column.Afterwards the table could be adjusted and the procedure was finished with the affected table.There was a delay of approximately 30 minutes due to this incident.Manufacturer reference # (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet gmbh, kehler strasse 31, rastatt, germany 76437.Exemption # e2018004.Getinge usa sales, llc 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).The affected table was sent to workshop and repaired and investigated by getinge.Concerning the trend movement the investigation revealed the following: the malfunction described by the customer could not be reproduced.No defects at parts related to the described malfunction were found.Oil and disinfectant were found on other parts inside the table.We assume that most probably, a small particle has blocked one of the valves (internal leakage) and this has caused the table to move into the trendelenburg position.It was most likely washed out once the valve was operated.Therefore, this malfunction could not be reproduced.Since oil residue was found on other parts of the table, we assume a mistake during previous repair or service work has caused the particle to end up in the hydraulic system.We cannot determine whether the repair or maintenance work was performed by a getinge-maquet service technician, the hospitals biomed or a third party company.Maquet service technicians are trained and there are maintenance and repair instructions available.The last maintenance work on this table was performed on the first of march 2018.We assume that if the hydraulic system had been polluted during this maintenance, the malfunction would have occurred earlier.Therefore, we assume third party intervention to be the most probable root cause for this malfunction.In the instructions for use (ifu) the user is advised not to perform repair work: "a defective product may not be used and may not be repaired by yourself".Concerning the affected remote control, the following was found: there were traces of disinfector on the gland for the remote control.It was defective and was replaced.In case the remote control is defective, the table can be operated via the override panel.In the ifu the user is advised to check the product prior to use for functional and mechanical integrity.The function of the override panel is described in the ifu.Investigation of the remote control showed that there was a short circuit on its pcb.We assume that this has most likely occurred due to inappropriate cleaning.In the ifu, the user is advised on how to clean the remote control.Maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

Manufacturer reference # (b)(4).

• Brand Name: ALPHASTAR MOBILE OPERATING TABLE
• 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: 8361401
• MDR Text Key: 139068971
• Report Number: 8010652-2019-00007
• 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: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113211A2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other