MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAGNETOM ESPREE; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number 10018165

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens is a distributor of the mri gurney/stretcher and provides it as an accessory to siemens devices.The reported incident occurred with the stretcher with material number 7437549.The manufacturer of the stretcher - aga sanitaetsartikel gmbh - made improvements in 2010 by implementing a cross brace to stabilize the stretcher.The photos of the concerned stretcher at the site show that it had not been updated with this feature.In addition, the operator manual of the mri patient stretcher was updated with a caution notice of bumps on the floor.The investigation is on-going.A supplemental report will be submitted if additional information is received.Internal id # (b)(4).

Event Description

Siemens became aware of an incident that occurred with a patient gurney.An intubated and ventilated patient was being brought into an mri exam room on a gurney.When the user pushed the gurney into the examination room, the underframe of the mri stretcher broke off at the head end while passing over a short threshold (approximate level 1-2 cm).The user was able to catch the head end and slowly put it on the floor.The patient was repositioned and taken to the exam room to complete the examination.There are no injuries attributed to this event.The reported incident occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.The investigation of the provided picture showed that the table underframe on the affected mri patient stretcher broke apart.According to the received information, this issue happened while a patient was on this stretcher.No injury was reported for this occurrence.The manufacturer of the mri patient stretcher is aga sanitätsartikel gmbh.In 2010 the mri patient stretcher received an upgrade by implementing a cross brace to further stabilize the stretcher.The provided picture confirmed that the concerned mri patient stretcher was not upgraded with the cross brace.A caution notice was also added to the operator manual (aga id fq.7.5.5.203.10) of the mri patient stretcher stating that it was not designed to be pushed over bumps on the floor.In 2013 several customer orders were found with this particular type of the aga stretcher.At the end of 2013 and the beginning of 2014, a customer safety advisory notice had been sent out to the affected customers to contact the manufacturer aga to receive the upgrade kit to stabilize the stretcher.During this investigation, it was determined that 19 customers in germany were not addressed with the advisory notice.This customer - (b)(6)- was one of these users.Therefore, measures were initiated to determine why not all relevant customers were addressed in 2013/ 2014 with the advisory notice.The affected customer already received the upgraded aga mri stretcher.The issue was investigated in detail.The investigation of the provided picture showed that the table underframe on the affected mri patient stretcher broke apart.According to the received information this issue happened while a patient was on this stretcher.No injury was reported for this occurrence.

• Brand Name: MAGNETOM ESPREE
• Type of Device: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; forchheim, 91052 ; GM 91052
• MDR Report Key: 11019852
• MDR Text Key: 252455464
• Report Number: 3002808157-2020-58247
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K123938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10018165
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 110