TRANSWARMER INFANT TRANSPORT MATTRESS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-05 for TRANSWARMER INFANT TRANSPORT MATTRESS * manufactured by Cooper Surgical.

Event Text Entries

[621640] Extremely low birthweight infant, born by vaginal delivery with apgars of 5 at one minute 8 at 5 minutes was delivered, dried, stimulated, intubated, given survanta, placed on a seated transport isolette on a transwarmer infant transport mattress, shown to mom, and wheeled down the hall to the nicu. Infant, admitted to the nicu. At that time, the patient was hypothermic with a temperature of 35a? C. The transwarmer from the delivery room was placed under the infant when the infant was moved from the transport isolette to the radiant warmer. The infant was on the radiant warmer for approximately 3 hours following admission. Subsequently, the patient was moved from the radiant warmer to an isolette without the transwarmer. At change of shift, nursing, noted, what they thought was an abrasion on the lower back. Later, the area became more clearly demarcated as a 51/2 cm x 3 cm reddened area with a small open area in the lower aspect. It was diagnosed as a 2nd degree burn. Physician assessed the burn and prescribed bactroban ointment 3 times a day. Burn completely healed without any escalation of care. No skin grafts required. This event is being reported voluntarily because no one has ever observed any issues with this product, which is used extensively for neonate after delivery for transport purposes. Manufacturer's instructions are that this device will warm to 40a? C. Once the silver disk is compressed. The unit manager re-created the scenario after the event. She was able to obtain temperature ranges between 40. 2a? C and 40. 6a? C taken with the temperature probe beneath the transwarmer and the mattress, and also on top of the transwarmer patient side surface and the radiant warmer head. It took about five minutes for the device to reach the range of temperatures listed. The patient was placed correctly on the transwarmer patient side surface.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number882204
MDR Report Key882204
Date Received2007-07-05
Date of Report2007-07-05
Date of Event2007-05-30
Report Date2007-07-05
Date Reported to FDA2007-07-05
Date Added to Maude2007-07-19
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTRANSWARMER INFANT TRANSPORT MATTRESS
Generic NameMATTRESS, WARMER, INFANT
Product CodeFOH
Date Received2007-07-05
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Age1 DY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key860926
ManufacturerCOOPER SURGICAL
Manufacturer Address95 CORPORATE DRIVE TRUMBULL CT 06611 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-07-05

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