MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES MULTIX FUSION WIRELESS; SYSTEM, X-RAY, STATIONARY

Model Number 10893300

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

The reported incidents were captured as complaints.The conclusion from the complaint investigation indicates that the loss of images was due to image recover failure, which occurred sporadically due to a software bug that interfered with wireless transmission.In one of the reported occurrence the acquired image was recoverable, however image recovery procedure outlined in the system manual was not followed resulting in image loss.The investigation results show that these malfunctions would not cause or contribute to death or serious injury.Siemens will provide a software update to resolve the software bug and eliminate the likelihood of re-occurrence of the reported incidents.

Event Description

On november 7th, 2016, siemens received a medsun report # (b)(4) filed by a user facility.The report stated that the system displayed an error ""image transfer delay" after the exposure was taken.The unit had to be re-started in each case and the images had to be re-taken on the same or different machine.There are no injuries attributed to these events.

• Brand Name: MULTIX FUSION WIRELESS
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 8560209
• MDR Text Key: 145916431
• Report Number: 3004977335-2016-52366
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10893300
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1