MAUDE Adverse Event Report: HOLGER ULLRICH ALPHAMAXX LV 460, EU, SW-80; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 113322B4

Device Problem Unintended System Motion (1430)

Patient Problems Laceration(s) (1946); Physical Entrapment (2327)

Event Date 12/25/2017

Event Type  Injury  

Manufacturer Narrative

Maquet service technician was on site and investigated the product.During the investigation it turned out that a patient warming device was placed under the operating table.When the table was lowered during the procedure the leg plate of the table collided with the patient warming device.The base of the operating table was raised a bit unnoticed by the user.Over time the patient warming device broke, the operating table lowered abruptly and the base of the table fell on the user's foot.The foot was injured and the wound needed to be stitched but there was no broken bone.No permanent damage was reported to maquet.There was no delay in the procedure due to this issue.The procedure was finished by another physician.During the investigation no malfunction of the operating table was detected.The incident was caused by use error.In the instruction for use (ifu) it is stated that the user has to pay attention and remove potential hindrances before moving / adjusting the mobile operating table and avoid collisions.There was no malfunction of the maquet device.The injury was caused by use-error.Getinge - maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

It was reported to maquet that a user (physician) got injured during a operation.The table dropped and the user¿s foot got stuck under the operating table.The foot was injured and the wound needed to be stitched but there was no broken bone.(b)(4).

• Brand Name: ALPHAMAXX LV 460, EU, SW-80
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet gmbh; kehler strasse 31,; rastatt 76437
• MDR Report Key: 7160619
• MDR Text Key: 96330851
• Report Number: 8010652-2018-00001
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 113322B4
• Device Catalogue Number: 113322B4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention