MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-09-22 for SMART SCALE 56320 manufactured by Natus Medical Incorporated.
[87860170]
Natus medical investigator found that the smart scale an obsolete model of 10 year old or older, (discontinued 03/2007) at the time of the complaint. The customer stated in the medwatch event description that the "cord cap" on the scale was damaged. A "cord cap" is not a part described in the user manual, but it is most likely the plug on the end of the power cord. Without any customer information, this is unable to be confirmed. A damaged power plug could have led to electric shock. All models of this device will be designed and certified to meet iec 60601-1-2. No other smart scale complaints were found involving electric shock for olympic smart scale products. No further investigation is possible.
Patient Sequence No: 1, Text Type: N, H10
[87860171]
Natus medical received a medwatch report #5071443, on (b)(6) 2017. Medwatch nurse reportedly received a mild shock when the "plug blew" on an olympic smart scale model 20 (model #56320) plugged into an outlet. No indication is given as to the nurse's position or actions at the time of the shock. A biomedical engineer reported that the "cord cap" on the scale appeared to be damaged, so the "cord cap" was replaced with a new one. The scale was inspected and then returned to service. An electrician at the hospital stated that the outlets in the room were in good working order. No indication is given as to the outcome of the nurse that received a shock, but it is noted on the medwatch report that the event was a "serious injury" that "required intervention. " the olympic smart scale model 20 was sold beginning in 1986 and discontinued in march 2007. Because no serial number was provided in the medwatch report, the customer's device could be at least 10 to 30 years old. No customer or company contact information was provided in the medwatch report supplied to natus by fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00726 |
| MDR Report Key | 6888859 |
| Report Source | USER FACILITY |
| Date Received | 2017-09-22 |
| Date of Report | 2017-08-25 |
| Date Mfgr Received | 2017-08-25 |
| Device Manufacturer Date | 2014-11-07 |
| Date Added to Maude | 2017-09-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARC RIVAS |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685142 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART SCALE |
| Generic Name | SMART SCALE 20 (OBSOLETE) |
| Product Code | FRW |
| Date Received | 2017-09-22 |
| Model Number | 56320 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-22 |