FDA.reportPublic FDA data

MAUDE MDR 7850151

MDR report key
7850151
Report number
7850151
Event key
0
Event type
3
Date of event
2018-08-20
Date received
2018-09-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SECA 286SCALE, STAND-ON, PATIENTSECA CORP.FRI286* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-060

Event Narratives#

D

Patient 1

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.