SPACELABS MULTIGAS ANALYZER MODULE
Received May 8, 2012 · Event occurred Apr 15, 2012
Report 3023361-2012-00021 · MDR key 2564445
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
SPACELABS RECEIVED INFORMATION THAT ALLEGES THAT A MULTIGAS ANALYZER MODULE FAILED.
Description of Event or Problem
SPACELABS RECEIVED INFORMATION THAT ALLEGES THAT A MULTIGAS ANALYZER MODULE FAILED.
Additional Manufacturer Narrative
THE CUSTOMER REPORTED THREE DEVICE FAILURES AND STATED THAT THEY WERE SAFETY ISSUES. WE FILED AN MDR BECAUSE OF THE CUSTOMER'S CONCERN. WE DOCUMENTED THE OTHER TWO IN MDRS 3023361-2012-00019 AND 3023361-2012-00020. THE BIOMED IN THE HOSPITAL SOLVED THE ISSUE BY TIGHTENING A LOOSE CONNECTOR/CABLE. THE DEVICE WAS RETURNED TO SERVICE AND IS WORKING TO SPECIFICATIONS. THE CUSTOMER WAS UNABLE TO PROVIDE THE SERIAL NUMBER OF THE DEVICE IN QUESTION. A REVIEW OF AVAILABLE DATA IN THE COMPLAINT DATABASE DOES NOT INDICATE THAT THIS MALFUNCTION IS PART OF A TREND. NO ONE HAS BEEN INJURED AS A RESULT OF THIS FAILURE. WE HAVE CONCLUDED THAT THIS REPORT IS FINAL AND CONSIDER THIS ISSUE CLOSED.
Additional Manufacturer Narrative
SPACELABS IS WORKING TO CONTACT THE HOSPITAL TO OBTAIN DETAILS OF THE REPORTED EQUIPMENT MALFUNCTION. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. WE WILL PROVIDE A SUPPLEMENTAL REPORT ONCE OUR INVESTIGATION IS COMPLETE.
Remedial action
- Repair