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

Model Number 720001BO

Device Problems Component Falling (1105); Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was reported by the clinic that the table top of the operating table dropped approximately 10 cm in height at the beginning of the procedure.The patient was transferred to another table and the procedure was completed.No injury to the patient or user was reported to getinge.Maquet service technician visited the clinic and investigated the device.At the time of this report the final investigation results were not available.Getinge- maquet (b)(4) provides failure investigation , analysis and resolution for the device described in this report.

Event Description

It was reported that the table top of the operating table dropped approximately 10 cm in height at the beginning of the procedure.Mfg reference # (b)(4).

Event Description

Mfg reference # (b)(4).

Manufacturer Narrative

It was reported by the clinic that the table top of the operating table dropped approx.10 cm in height at the beginning of the procedure.This kind of malfunction could be caused by a mechanical or electrical malfunction.A getinge-maquet service technician visited the clinic and investigated the product in question.The service tech reported that no defect or damage could be found at the table.Therefore we exclude a mechanical malfunction has caused the described issue.The electrical board that could have caused this malfunction was returned to getinge-maquet and forwarded to our supplier for further investigation.The board was tested by the supplier and no malfunction of the board could be found.The manufacturing documentation of this board was reviewed and no indications were found.After the table was investigated and the board was swapped, no other malfunction was reported.Because no mechanical or electrical malfunction or damage could be detected at the table and no other malfunction was reported afterwards, we assume that there was no product malfunction of this table.Technical support was asked what kind of malfunction might cause the described issue.The assessment by technical support was that the collision could lead to the described malfunction.Such a malfunction can occur in case the table top is touching an object which stands underneath the table while it is moved downwards.The object blocks the tables downward movement.Once this object breaks or is damaged or removed the table top lowers in the way described b the customer.In the instructions for use (ifu) the user is warned regarding these kinds of collisions.Quote (b)(4): "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 able and accessories and avoid collisions.Ensure the tubes, cables, and drapes are not trapped." "risk o injury! when setting down the or table, there is a risk of crushing and shearing to the feet or objects.Before putting down the or table, make sure there are no objects located under the or table base.When lowering the or table, keep sufficient distance to the or table base." getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet gmbh (b)(4).Exemption # e2018004.(b)(4), contact person: (b)(6).

• 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
• MDR Report Key: 7497969
• MDR Text Key: 108248633
• Report Number: 8010652-2018-00008
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 720001BO
• Device Catalogue Number: 720001BO
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1