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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENERAL ELECTRIC CO. PANDA IRES WARMER RADIANT INFANT WARMER

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GENERAL ELECTRIC CO. PANDA IRES WARMER RADIANT INFANT WARMER Back to Search Results
Device Problems Mechanics Altered (2984); Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2016
Event Type  malfunction  
Event Description
Concern: the compressed tank holding rack is not secure and possesses potential for employee injury. The oxygen and air tank holding rack does not support the weight of the tank during the set up causing awkward body positioning that can cause back or knee strain. The open bottom of the tank holding system increases the potential for an accidental release of a compressed gas tank during set up and or use during transport increasing the opportunity of bodily harm to patient or user.
 
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Brand NamePANDA IRES WARMER
Type of DeviceRADIANT INFANT WARMER
Manufacturer (Section D)
GENERAL ELECTRIC CO.
3000 n grandview blvd.
mail code w440
waukesha WI 53188
MDR Report Key5856177
MDR Text Key51497248
Report Number5856177
Device Sequence Number1
Product Code FMT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/01/2016,08/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2016
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/01/2016
Event Location Hospital
Date Report to Manufacturer08/01/2016
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

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