MalfunctionBZQ
MP5
Received Dec 29, 2020
Report 9610816-2020-00486 · MDR key 11088685
Device
Product problems
- Therapeutic or Diagnostic Output Failure
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER REPORTED A SPEAKER MALFUNCTION INOP ON THEIR INTELLIVUE MP5 PATIENT MONITOR. THE DEVICE WAS NOT IN CLINICAL USE.
Additional Manufacturer Narrative
SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.