My HPRA: Register

SC7000 & SC9000 Patient Monitors

Notice type: Warning

Date: 26/02/2003

  

Product name or type:
SC7000 & SC9000 Patient Monitors

Reference:
SN2003(03)

Manufacturer Or Supplier:
Siemens Medical

Target Audience:
Clinical Engineering Departments; Medical Physics Departments; Equipment Managers; Medical, Nursing and Care Staff; Risk Managers; Lifting and Handling Trainers

Problem Or Issue:
Failure of the handle on a patient monitor.

Background Information Or Related Documents:
When a monitor was being removed from over a patient's bed (in the USA) the handle broke resulting in the monitor hitting the patient''s head. The impact resulted in serious head injuries and death.   

The manufacturer of the device has implemented a corrective action, advising all users of the product of the potential problem and replacing the handles on those devices manufactured before August 2000.   

Precautions should be taken when lifting all equipment to ensure that there is not risk to either staff or patient.

SC7000 & SC9000 Patient Monitors Document

Actions To Be Taken:
  • Determine if you have these devices in use in your centre.
  • Ensure that you have received the Advisory Notice that was circulated by the manufacturer.
  • Ensure the manufacturer replaces the handles on the device.
  • Ensure that all staff is advised of the potential problem with handling of heavy equipment.
  • Ensure that local procedures emphasise the importance of care when lifting heavy equipment, particularly indicating not to lift heavy items over patients.

Further Information:
All adverse incidents relating to a Medical Device should be reported to the:   

Medical Devices Department 
Health Products Regulatory Authority
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2   

If you have any enquiries, you may contact the Medical Devices Department at:   

Telephone:        +353-1-6764971 
Fax:                  +353-1-6767836 
Email:               vigilance@imb.ie 
Website:            www.hpra.ie

Enquiries to the manufacturer should be addressed to:   
Gerard O'Brien 
Siemens Limited 
8 Raglan Road 
Dublin 4   

Telephone:        +353-1-2162000
Fax:                  +353-1-2162399 

SN2003(03): SC7000 SC9000 Patient Monitors

« Back