SECA 286
Received Sep 6, 2018 · Event occurred Aug 20, 2018
Report 7850151 · MDR key 7850151
Device
Product problems
- Calibration Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
WHEN PERFORMING A DEVICE CALIBRATION/FUNCTIONALITY CHECK ON THE SCALE, THE BIOMED ENGINEER DISCOVERED AN INCREASE OF 100 CM ON THE ACTUAL CALIBRATED ROD HEIGHT READING WHICH SHOULD BE AT 81.5 CM. UNIT CALIBRATION CHECK IS PERFORMED WITH A MANUFACTURER SUPPLIED CALIBRATION ROD THAT MEASURES 81.5 CM WHICH SHOULD BE READ BY THE SCALE DURING THE FUNCTIONALITY CHECK PROCESS. THE SECA 286 SCALE COMES WITH THE OPTION OF THREE PAIRS OF ULTRASONIC SENSORS LOCATED AT THE TOP OF THE UNIT THAT RECORDS PATIENT'S HEIGHT IN MILLISECONDS WHICH ARE THEN ELECTRONICALLY FED TO THE ELECTRONIC MEDICAL RECORD (EMR). IF ANY OTHER SONAR EMITTING DEVICES, FOR EXAMPLE, A SONAR EQUIPPED LIGHT SWITCH FIXTURE, COMMONLY USED TO CHECK FOR ROOM OCCUPANCY TO TURN AND KEEP LIGHTS ON OR OFF ARE IN THE VICINITY OF THE SCALE, IT COULD CAUSE INCORRECT MEASUREMENT ON THE HEIGHT READING, WITHOUT ANY WARNINGS COMING FROM THE SCALE.