MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG AXIOM MULTIX, MP; TABLE, RADIOGRAPHIC, NON-TILTING, POWERED

Model Number 08395431

Device Problems Electrical Power Problem (2925); Material Split, Cut or Torn (4008)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: siemens healthineers requested that the customer not use the affected system further until repair has been completed.No general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: the cause for the damage to the high voltage cable is under investigation.The investigation is ongoing.Siemens healthineers will submit a supplemental report if additional information is obtained upon completion of the investigation.

Event Description

A siemens healthineers service engineer discovered that the high voltage cable to the x-ray tube assembly of an axiom multix, mp system was damaged.He stated that the cable insulation had partially melted.The customer had wrapped tape around the damaged parts of the cable.There was no injury associated with this issue.There is only high voltage to the cable during the short time when radiation is released and a few seconds afterwards.In the unlikely event that a person touched the affected cable during this time and received an electrical shock, a serious injury could result.

• Brand Name: AXIOM MULTIX, MP
• Type of Device: TABLE, RADIOGRAPHIC, NON-TILTING, POWERED
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 18520582
• MDR Text Key: 333248529
• Report Number: 3004977335-2024-00005
• Device Sequence Number: 1
• Product Code: IZZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08395431
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/04/2024
• 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