MAUDE Adverse Event Report: SIEMENS AG AVANTO FIT; SYSTEM, NUCLEAR MAG. RES. IMAGING

Model Number 10849579

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 07/21/2014

Event Type  Injury  

Event Description

It was reported to siemens that during the upgrade of an avanto system to an avanto fit system, the cold head temperature sensor cable on the cold head needed to be disconnected.When the sensor cable was unplugged from the cold head the plastic cap of the sensor port suddenly became loose and fell off.Extreme cold helium gas could escape through the port.The unprotected right and left hand of the service engineering received second degree burns requiring inpatient treatment.The servicing of the system is only performed by trained service personnel and at no time were patients or operators at risk of any adverse event.

Manufacturer Narrative

Siemens is currently conducting an investigation of the reported issue.Root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.The complaint was initially received and classified as a workmen's error with a minor injury, however, on (b)(6) 2014, additional info was provided regarding the engineers injury.Due to the nature of the engineers injury, the complaint was re-classified as a reportable event.This event occurred in (b)(6).

• Brand Name: AVANTO FIT
• Type of Device: SYSTEM, NUCLEAR MAG. RES. IMAGING
• Manufacturer (Section D): SIEMENS AG
• Manufacturer (Section G): SIEMENS AG
• Manufacturer Contact: meredith adams ; 51 valley stream pkwy.; d02; malvern, PA 19355 ; 6104483237
• MDR Report Key: 4036798
• MDR Text Key: 16175051
• Report Number: 2240869-2014-06285
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10849579
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2013
• 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
• Patient Outcome(s): Hospitalization