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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED SMART SCALE SMART SCALE 20 (OBSOLETE)

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NATUS MEDICAL INCORPORATED SMART SCALE SMART SCALE 20 (OBSOLETE) Back to Search Results
Model Number 56320
Device Problem Device Operational Issue (2914)
Patient Problem No Code Available (3191)
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
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.
 
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Brand NameSMART SCALE
Type of DeviceSMART SCALE 20 (OBSOLETE)
Manufacturer (Section D)
NATUS MEDICAL INCORPORATED
5900 first avenue south
seattle WA 98108
Manufacturer (Section G)
NATUS MEDICAL INCORPORATED
5900 first avenue south
seattle WA 98108
Manufacturer Contact
marc rivas
5900 first avenue south
seattle, WA 98108
2062685142
MDR Report Key6888859
MDR Text Key87860170
Report Number3018859-2017-00726
Device Sequence Number1
Product Code FRW
Combination Product (y/n)N
PMA/PMN Number
K934930
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 08/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number56320
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received08/25/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/07/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/22/2017 Patient Sequence Number: 1
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