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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WIPRO GE HEALTHCARE PRIVATE LTD. LULLABY WARMER WARMER, INFANT RADIANT

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WIPRO GE HEALTHCARE PRIVATE LTD. LULLABY WARMER WARMER, INFANT RADIANT Back to Search Results
Model Number 2041599-001
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Death (1802)
Event Date 08/28/2019
Event Type  Death  
Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. Patient information could not be obtained due to country privacy laws. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported that the patient received burns due to prolonged exposure to high heat of the warmer. The patient passed away.
 
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Brand NameLULLABY WARMER
Type of DeviceWARMER, INFANT RADIANT
Manufacturer (Section D)
WIPRO GE HEALTHCARE PRIVATE LTD.
4, kadugodi industrial area,
bangalore 56006 7
IN 560067
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key9100310
MDR Text Key159427963
Report Number9617277-2019-00003
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
PMA/PMN Number
K121625
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2041599-001
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/20/2019 Patient Sequence Number: 1
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