MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY ARTIS ZEE BIPLANE; SYSTEM, XRAY, ANGIOGRAPHIC

Model Number 10094141

Device Problem Material Integrity Problem (2978)

Patient Problem Pressure Sores (2326)

Event Date 12/23/2015

Event Type  malfunction  

Manufacturer Narrative

Siemens conducted an investigation of the system and table mattress.No defect was found and the system and components are operating as specified.

Event Description

It was reported to siemens that a customer experienced a problem with the mattress used during a procedure on the artis zee biplane.The customer stated the mattress did not provide sufficient cushioning and the patient noted a sacro iliac pressure sore.The hospital administered routine first aid and dressing for the ulcer.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Additional information for investigation was requested, however, not supplied.The problem was allocated to a mattress used for patient positioning during the procedure.The mattress in doubt is not a siemens medical device.The manufacturer is not considering further actions resulting from this individual event.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, XRAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 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: 5433318
• MDR Text Key: 38083560
• Report Number: 2240869-2016-31441
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10094141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/08/2017
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/12/2016
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2008
• 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