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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED OLYMPIC SMART SCALE SCALE, PATIENT

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NATUS MEDICAL INCORPORATED OLYMPIC SMART SCALE SCALE, PATIENT Back to Search Results
Model Number NATUS OLYMPIC SMART SCALE 70
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Event Description
A second natus/olympus smart scale 70 within two months, who's ac adapter clip broke off. While this is caused by user error (moving scale before disconnecting) it is poorly made and should not break so easy!.
 
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Brand NameOLYMPIC SMART SCALE
Type of DeviceSCALE, PATIENT
Manufacturer (Section D)
NATUS MEDICAL INCORPORATED
5900 first ave., south
seattle WA 98108
MDR Report Key12480439
MDR Text Key271669963
Report Number12480439
Device Sequence Number1
Product Code FRW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNATUS OLYMPIC SMART SCALE 70
Device Catalogue Number53670
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/14/2021
Device Age7 YR
Event Location Hospital
Date Report to Manufacturer09/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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