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

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!.

• Brand Name: OLYMPIC SMART SCALE
• Type of Device: SCALE, PATIENT
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5900 first ave., south; seattle WA 98108
• MDR Report Key: 12480439
• MDR Text Key: 271669963
• Report Number: 12480439
• Device Sequence Number: 1
• Product Code: FRW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NATUS OLYMPIC SMART SCALE 70
• Device Catalogue Number: 53670
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2021
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1