MAUDE Adverse Event Report: HOLGER ULLRICH ALPHAMAXX SURGICAL TABLE W AUTO DRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 113322F3

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Head Injury (1879); Laceration(s) (1946)

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is ongoing at this time.Upon completion a follow-up medwatch will be submitted.

Event Description

It was reported that at the end of a procedure the head end of the or table moved and the patient slid from the table hitting his head.This resulted in a laceration requiring sutures and a ct scan.(b)(4).

Event Description

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.(b)(4), contact person: (b)(6).Initially the customer reported the following malfunction : the end head of the or table moved and the patient slid off the table.A getinge- maquet service tech visited the customer and investigated the device.The described malfunction could not be reproduced.The service tech reported that no one in the room actually saw the table move on its own.After the service tech investigation we assume that the patient was not secured properly on the table.The size of the patient and the angle of the table might have contributed to this event.In the instructions for use (ifu)-the customer is warned that the patient can slip off the table if not secured properly.Quote- ifu " warning! risk of injury! if the patient is not secured during positioning, when adjusting the or table or when positioning the patient (especially when the inclination and /or tilt feature is used), then the patient could slip off the table top in a uncontrolled manner or their legs and legs may hang down.Always secure the patient using suitable aids (e.G.Straps)and maintain continuous observation.And "note if a patient is on the or table: secure the patient prior to moving or adjusting the or table" the service technician inspected the table and found a slight leakage at one of the hydraulic cylinders.This kind of minor leakage could not result in the described malfunction.The leaking cylinder was repaired.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: ALPHAMAXX SURGICAL TABLE W AUTO DRIVE
• 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: 7833206
• MDR Text Key: 118784976
• Report Number: 8010652-2018-00017
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 113322F3
• Device Catalogue Number: 113322F3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/21/2019
• Event Location: Hospital
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other