MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SIREMOBIL COMPACT; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number 3776494

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.(b)(6).

Event Description

It was reported to siemens that a malfunction occurred following use of the siremobil compact system.The customer reported the image and monitor are black and it is not possible to see objects placed on the image intensifier.There is no report of impact to the state of health of any patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a defective power supply hv30-2 (pn:03830580).With the defective power supply, the image intensifier is powerless and cannot work.As a result, the image remains black, as mentioned in the complaint.The spare parts consumption of the power supply has been checked and no error accumulation has been recognized.The power supply has been exchanged on site by the local service organization and the error did not reoccur.The manufacturer is not considering further actions resulting from this event as no general systematic error has been recognized.

• Brand Name: SIREMOBIL COMPACT
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6556483
• MDR Text Key: 75003893
• Report Number: 3004977335-2017-77304
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

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: No Information
• Device Model Number: 3776494
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2017
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 05/10/2017
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 04/10/2018
• 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: N
• Patient Sequence Number: 1