SPACELABS MULTIGAS ANALYZER MODULE
Received May 8, 2012 · Event occurred Apr 15, 2012
Report 3023361-2012-00019 · MDR key 2564426
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 3023361-2012-00020 AND 3023361-2012-00021. THE SUBJECT DEVICE WAS FIRST SENT BY THE CUSTOMER TO THEIR SERVICE PROVIDER WHO WAS UNABLE TO FIX THE ISSUE. THE DEVICE WAS THEN RETURNED TO SPACELABS FOR REPAIR. SPACELABS REPLACED THE GAS BENCH AND SOLVED THE ISSUE. THE DEVICE WAS RETURNED TO THE HOSPITAL AND PUT BACK INTO SERVICE. THERE HAS BEEN NO FURTHER REPORT ON THIS ISSUE. THE GAS BENCH IS AN OEM PRODUCT. SPACELABS REPLACED THE GAS BENCH IN QUESTION AND RETURNED IT TO THE MANUFACTURER FOR INVESTIGATION AND TRENDING. GE HAS NOT INDICATED THERE IS A SIGNIFICANT TREND OF THIS FAILURE. 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