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

Model Number 720001B2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Injury (2348)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

No malfunction of the product was reported by the customer.In din en iso (b)(4): 2012 the risk of instability is considered in section 9.4.This section also deals with castors.In general the equipment used to transport mobile me equipment shall not pose an unreasonable risk if the me mobile equipment is moved or parked in accordance with its intended use (ref.(b)(4) general).For the purpose of the mobile operating table it is also necessary to move the table in the operating room area.Thus moving the operating table is intrinsically linked to the purpose.The residual risk correlates with the attention / alertness of the user and the ability to detect pinching and shearing points (also by collision / passing over) at an early stage.Thus the probability of occurrence is estimated to be low but not unimaginable.The residual risk can be accepted in relation to the state of the art.The product is usually in front of the user during use so he pushes and navigates the product independently of its orientation.The user must ensure that he does not collide with the environment or equipment or with a third party or as in this case squeezes his foot under the product.In chapter 2 of the ifu possible hazards are stated."risk of injury! when adjusting, moving or storing the or table / table top, the staff, the patient and the accessories are exposed to pinching and shearing hazards, particularly in the area around the joints at the head rest, back and leg plates.Always ensure that no one can be subjected to pinching or shearing action or injured in any other way and that the accessories do not collide with any nearby objects.

Event Description

The customer reported that a nurse injured his foot while maneuvering the operating table with traction drive.When going backwards the foot got under the operating table.The nurse squeezed his big toe so that a hematoma developed.In this case it was further reported that the incident occurred on the surgical floor where pvc floor is laid and the shoes do not slip on the floor.A similar incident occurred in the past with another nurse.The nurse suffered a bone fissure and was unable to work for one week.In no case permanent harm was reported.Mfg 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
• 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: 7291901
• MDR Text Key: 100775319
• Report Number: 8010652-2018-00004
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/23/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 720001B2
• Device Catalogue Number: 7200001B2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2016
• 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): Other