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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPIC NOW KNOWN AS NATUS MEDICAL OLYMPIC NEONATAL SCALE

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OLYMPIC NOW KNOWN AS NATUS MEDICAL OLYMPIC NEONATAL SCALE Back to Search Results
Model Number 56320
Device Problem Circuit Failure (1089)
Patient Problem Electric Shock (2554)
Event Date 07/24/2017
Event Type  Injury  
Event Description
Olympic neonatal scale plugged into outlet and plug blew and nurse received mild shock. Investigation of equipment by bio-med engineering revealed the cord cap on the scale was damaged. The cord cap was replaced and the scale was checked and returned to service. Hospital electrician also checked all the outlets in the room and they were found to be in good working order.
 
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Brand NameOLYMPIC
Type of DeviceNEONATAL SCALE
Manufacturer (Section D)
OLYMPIC NOW KNOWN AS NATUS MEDICAL
MDR Report Key6776677
MDR Text Key82370042
Report NumberMW5071443
Device Sequence Number0
Product Code FRW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number56320
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/07/2017 Patient Sequence Number: 1
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