MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-14 for SECA 644 manufactured by Seca Corp..
[28152523]
Patient Sequence No: 1, Text Type: N, H10
[28152524]
When a patient is weighed it is difficult for the staff to navigate from pounds to kilos or vice versa. Staff always think this device is broken because they cannot navigate the menu. Needs to have better instruction on how to navigate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5147788 |
| MDR Report Key | 5147788 |
| Date Received | 2015-10-14 |
| Date of Report | 2015-09-29 |
| Date of Event | 2015-09-28 |
| Report Date | 2015-09-29 |
| Date Reported to FDA | 2015-09-29 |
| Date Reported to Mfgr | 2015-09-29 |
| Date Added to Maude | 2015-10-14 |
| 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 | BIOMEDICAL ENGINEER |
| 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 |
| Generic Name | SCALE |
| Product Code | FRW |
| Date Received | 2015-10-14 |
| Model Number | 644 |
| Operator | NURSE |
| Device Availability | * |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-10-14 |