MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP SYMBIA S; GAMMA CAMERA

Model Number 8717741

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 05/08/2014

Event Type  Death  

Event Description

A patient was presented for a nuclear medicine study.The patient was positioned on the patient handling system (the patient bed associated with the system).The patient was left unattended and fell off the patient handling system and reportedly sustained an injury to the head.During siemens' follow-up with the site for additional information on (b)(6) 2014, it was reported that the patient was removed from life support and had expired.Siemens was not able to obtain information regarding the reason the patient was removed from life support or any potential relationship to the fall from the patient handling system or the patient's preexisting condition; cancer.Local service engineer investigated the system associated with the incident and confirmed the patient handling system was functioning properly and no device defects or malfunctions were found.The system was not in motion at the time of the incident.A review of the product user manual indicated that the product labeling adequately instructs users to monitor the patients at all times while on the system and that it is the user's responsibility to monitor the system to avoid any risk of injury.

Manufacturer Narrative

This supplement provides the "date received by manufacturer" information.

• Brand Name: SYMBIA S
• Type of Device: GAMMA CAMERA
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP; 2501 north barrington rd.; hoffman estates IL 60192
• Manufacturer Contact: laura meyer ; 2501 n. barrington rd.; hoffman estates, IL 60192 ; 8473046022
• MDR Report Key: 3834418
• MDR Text Key: 4393320
• Report Number: 1423253-2014-00003
• Device Sequence Number: 1
• Product Code: IYX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8717741
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Weight: 127