MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-06 for SECA 286 manufactured by Seca Corp..
[119347723]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7850151 |
| MDR Report Key | 7850151 |
| Date Received | 2018-09-06 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-08-20 |
| Report Date | 2018-08-28 |
| Date Reported to FDA | 2018-08-28 |
| Date Reported to Mfgr | 2018-09-06 |
| Date Added to Maude | 2018-09-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SECA 286 |
| Generic Name | SCALE, STAND-ON, PATIENT |
| Product Code | FRI |
| Date Received | 2018-09-06 |
| Model Number | 286 |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECA CORP. |
| Manufacturer Address | 13601 BENSON AVE CHINO CA 91710 US 91710 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-06 |