MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH LUMINOS AGILE; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 10502200

Device Problem Break (1069)

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

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

The footboard was replaced at the affected site.The investigation is on-going.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

It was reported to siemens that while the user was installing the footboard, pins on the footboard broke.There was no patient involvement and no injury occurred.The user noticed the damage before usage and the footboard was replaced.There is a note in the operator manual to check the correct attachment of the footboard before use.In a worst-case scenario, if the user did not notice the damage before usage, the issue might lead to a minor to serious injury if the footboard detached unexpectedly from the table while a patient was standing on it.This event has been reported as a precaution and for consistency reasons.

Manufacturer Narrative

The reported event was investigated in detail.It was initially reported that while the user was installing the footboard, pins on the footboard broke.The complaint footboard was replaced, and the footboard was evaluated to find out which pins were associated with the reported event.After an optical analysis of the footboard, it was determined that one metal pin had broken off.These pins are responsible for fixing and holding the footboard on the tabletop.Per system experts, the most probable cause of the metal pins breaking is an unusual external mechanical force (e.G., by operator).The metal pins were likely pushed several times against the edge of the tabletop when installing the footboard onto the table.Under these conditions, the pins break off due to material stress.This is the first known issue with a broken pin at the foot support.No general problem is known.The correct attachment of the foot support to avoid such an issue is described within the system operator manual xpd1-320.620.01.02.02; chapter "accessories and auxiliary devices" page 73 - 75.The spare part consumption of the concerned foot support_230kg (material number 8893385) shows values that are below the defined threshold.The complaint is closed, and further action is not deemed necessary.Internal id#: (b)(4).

• Brand Name: LUMINOS AGILE
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14631672
• MDR Text Key: 295347210
• Report Number: 3004977335-2022-30315
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

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: 10502200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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