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

Model Number 8717741

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fracture, Arm (2351)

Event Date 05/30/2015

Event Type  Injury  

Event Description

Manufacturer narrative: siemens molecular imaging became aware on (b)(6) 2015 through a discussion with the risk manager at (b)(6) hospital, in (b)(6), that a pt injury occurred on (b)(6) 2015.The pt rolled off and fell from the patient handling system (system bed) resulting in a broken arm.The site risk manager stated that there was no malfunctions of the device as the pt was left unattended while sleeping and rolled off at the conclusion of the scan.The pt was awoken by the beep sound made at the end of the study.There were no product defects or labeling deficiencies found.The operator of the system was not harmed in this event.Customer narrative: "camera beeped at the end of a cardiac spect scan, this woke the pt.The pt rolled off the phs falling to the floor.Pt had ct scan and x-ray".

Manufacturer Narrative

During follow-ups on this complaint, we became aware on 06/22/2015 that the reported date of event ((b)(6) 2015) was incorrect.The correct date of event ((b)(6) 2015) is being submitted via this supplement report.

• 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 north barrington rd.; hoffman estates, IL 60192 ; 8473046022
• MDR Report Key: 4860087
• MDR Text Key: 16561949
• Report Number: 1423253-2015-00005
• Device Sequence Number: 1
• Product Code: IYX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2015

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: Health Professional
• Device Model Number: 8717741
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 06/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2008
• 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): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 119