MAUDE Adverse Event Report: HOLGER ULLRICH ALPHASTAR PRO, EU, SFC, LOW; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 113222B0

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

Patient Problem Bone Fracture(s) (1870)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).No malfunction of the product was reported by the customer.A (b)(4) - maquet service engineer visited the clinic, checked the affected table and confirmed that the table worked according to specification.The incident was caused by user error.In the instructions for use (ifu) it is stated the user is to pay attention and avoid collisions when operating the table.In chapter 2 of the ifu possible hazards are stated: "warning! risk of injury! when adjusting and moving the or table, the table top or the accessories, collisions may occur with the patient, between the individual products or parts pointing downwards.During the adjustment procedures, always pay attention to the or table and accessories and avoid collisions.Ensure that tubes, cables and drapes are not trapped." "warning! 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, 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." maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

The customer reported that a doctor broke his right toe while using the operating table.The leg plates of the table pointed downwards in an 90° angle and the table was lowered.The leg plates touched the ground and when the table was lowered further the movement was blocked by the leg plates.As a result the table was lifted off the floor.The doctor's right toe got under the table.The leg plates were moved and the table hit the ground.The doctor's right toe which was under the table got pinched and his right toe got broken (bone broke).Manufacturer reference # (b)(4).

• Brand Name: ALPHASTAR PRO, EU, SFC, LOW
• 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: 8390211
• MDR Text Key: 137835275
• Report Number: 8010652-2019-00009
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/05/2019

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: 113222B0
• Device Catalogue Number: 113222B0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/05/2019
• 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): Other