SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
Received Jan 6, 2020
Report 3007409280-2020-00001 · MDR key 9555734
Device
Product problems
- Electrical /Electronic Property Problem
- Output Problem
- Unexpected Shutdown
- Electrical /Electronic Property Problem
- Output Problem
- Unexpected Shutdown
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. VISUAL EVALUATION FOUND NO ANOMALIES. DEVICE EVALUATION DETERMINED THAT THE DEVICE FALL TIME MEASUREMENT FAILED CONFIRMING THE REPORTED MALFUNCTION. THE MAIN BOARD WAS REFURBISHED. THE OM BOARD WAS REPLACED. A DEFINITIVE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED; HOWEVER, THE MOST PROBABLE CAUSE IS THAT THE DEVICE HAD BEEN DROPPED PREVIOUSLY DURING SHIPPING. NO FURTHER INVESTIGATION IS REQUIRED. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED. IT SHOULD BE NOTED THAT THIS IS BEING FILED BASED ON RETROSPECTIVE REVIEW.
Description of Event or Problem
REPORTEDLY, POST REPAIR, C02 WAVE PATTERN AND NUMBERS DISAPPEAR WHILE ON PATIENT. THERE WAS NO REPORT OF PATIENT HARM. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.