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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS MEDICAL INC. WARM SCALE 23

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NATUS MEDICAL INC. WARM SCALE 23 Back to Search Results
Model Number 56328
Device Problems Melted (1385); Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to natus for factory service inspection/repair. The service testing did not show any issues other than an older battery that was replaced to allow for further testing. There is no indication that the battery failed early or prematurely. The device passed all quality assurance testing and has been returned to the customer per normal repair procedure.
 
Event Description
A customer's biomed contacted natus technical service for the part number and pricing of the infant tray and shelf for the warm scale. When asked why replacements were required, the customer reported that the tray and the insert had melted areas. The customer went further to state that device was not in use with a patient when the issue was discovered and there were no environmental safety concerns. The customer stated that the clinical staff had been using the device to warm up a stack of cloths for patients. No death, harm or delay in patient procedures have been reported.
 
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Brand NameWARM SCALE 23
Type of DeviceWARM SCALE 23
Manufacturer (Section D)
NATUS MEDICAL INC.
5900 first avenue south
seattle WA 98108
Manufacturer (Section G)
NATUS MEDICAL INC.
5900 first avenue south
seattle WA 98108
Manufacturer Contact
jeffrey mantkowski
5900 first avenue south
seattle, WA 98108
2062685143
MDR Report Key7077516
MDR Text Key94674675
Report Number3018859-2017-00988
Device Sequence Number1
Product Code FRW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Remedial Action Repair
Type of Report Initial
Report Date 11/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number56328
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2010
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: 12/01/2017 Patient Sequence Number: 1
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