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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED WARM SCALE 28 TOP ASSY

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NATUS MEDICAL INCORPORATED WARM SCALE 28 TOP ASSY Back to Search Results
Model Number 500124-501
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2021
Event Type  malfunction  
Event Description
The customer contacted natus to report that the heating coil in their warm scale 28 was sagging/elongated, which resulted in melting of the tray and vented shelf. No patient injury.
 
Manufacturer Narrative
Initial report ref complaint# (b)(4). The customer contacted natus to report that the heating coil in their warm scale 28 was sagging/elongated, which resulted in melting of the tray and vented shelf. No patient injury. Product return for further evaluation and examination was requested, however, the customer decided to scrap the scale instead. (b)(4) was already generated in relation to this issue and design / manufacturing changes related to coil elongation were reviewed. Per doc (b)(4) warm scale 23 and 28 dhf remediation, it was determined that no design or manufacturing changes would occur because production of the warm scale product would be cancelled and no longer be manufactured effective april 1, 2018. The product risk level did not change and there was no changes to the design or function of the device. Per warm scale 23-28 risk analysis ra563120 rev f, pre-mitigation risk is medium. Hazard id 6. 8 addresses the risk associated with the reported failure with a severity of 3 and post-mitigation risk rating of low. A risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed. A dhr review is not applicable because, prior to the reported issue the device was in service for 2 or more years and a manufacturing defect is very unlikely. A search for service data that may have been relevant to this issue was conducted. No further information related to this issue was found. Investigation result code: seattle|heating element failure closure rationale:complaint verified, capa iniated or already open.
 
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Brand NameWARM SCALE 28 TOP ASSY
Type of DeviceWARM SCALE 28 TOP ASSY
Manufacturer (Section D)
NATUS MEDICAL INCORPORATED
5900 first avenue south
seattle, wa 98108 WA
Manufacturer (Section G)
NATUS MANUFACTURING LIMITED
ida business park
gort
galway, h91 pd92,
EI
Manufacturer Contact
gráinne walsh
5900 first avenue south
seattle, wa 98108, WA 
MDR Report Key11419596
MDR Text Key280447435
Report Number3018859-2021-00007
Device Sequence Number1
Product Code FRW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K952649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 03/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number500124-501
Device Catalogue Number500124-501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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