MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848282

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2023

Event Type  malfunction  

Event Description

Siemens became aware of an issue with the artis q biplane system.The velcro strap that secures mattress to the patient table came off.The mattress is now insecure and can slide sideways during patient positioning.This increases risk of patients potentially falling off the table, though, we are unaware of any adverse impact to the state of health of the patients involved.

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.As this event is under investigation yet been determined.A supplement report will be filed if additional information becomes available.H6: 4756 - velcro strap.

Manufacturer Narrative

During a service inspection, it was discovered that the velcro strap attached to the bottom of the tabletop, which is used to secure the mattress to the tabletop, had become loose.The purpose of this fixation is to prevent the movement of the mattress when there is no patient on the table and during patient transfer or positioning.However, velcro strap is not intended to prevent patient from sliding.Additional accessories, which are described in the instruction for use, must be used for this purpose.The same issue was found on a total of three different systems at the same facility.According to the information provided, the maintenance crew at the facility uses a lot of liquid during cleaning.Therefore, according to our expert opinion, the use of incorrect cleaning agents and/or large amounts of cleaning solution is the most likely cause of the velcro strips coming loose.The instruction for use contains adequate information and guidance on the use of cleaning materials.However, the issue has been discussed with the user to prevent further occurrence.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.

• Brand Name: ARTIS Q BIPLANE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234197
• MDR Report Key: 17595307
• MDR Text Key: 321641304
• Report Number: 3004977335-2023-00096
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: 04056869009995
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10848282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1