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

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.

• Brand Name: SMART SCALE
• Type of Device: SMART 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 Key: 6888859
• MDR Text Key: 87860170
• Report Number: 3018859-2017-00726
• Device Sequence Number: 1
• Product Code: FRW
• Combination Product (y/n): N
• PMA/PMN Number: K934930
• Number of Events Reported: 1
• 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 Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 56320
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other