TARRY MEDICAL PRODUCTS TEMPERATURE PROBES

Description of Event or Problem

ON (B)(4) 2012, OUR (B)(4) DISTRIBUTOR INFORMED US THAT AN INCIDENT WAS REPORTED THAT "A BABY SUFFERED FROM HYPERTHERMIA DESPITE THE TEMPERATURE DISPLAYED WAS ACCEPTABLE" IN AN OHMEDA 4400 WARMER USING A TARRY T97700 PROBE. WE REQUESTED A COPY OF THE INCIDENT REPORT AND THE RETURN OF THE PROBE FOR TESTING. ON (B)(4) 2012, WE ARE INFORMED BY DISTRIBUTOR THAT THE PROBE RETURNED ON (B)(4) 2012 FOR A ROUTINE COMPLAINT EVALUATION, SN (B)(4), WAS IN FACT THE PROBE INVOLVED IN THE REPORTED INCIDENT. REPEATED REQUESTS TO THE DISTRIBUTOR FOR MORE INFO HAVE BEEN UNSUCCESSFUL.

Additional Manufacturer Narrative

EVALUATION SUMMARY: SN (B)(4) WAS EVALUATED BOTH ELECTRICALLY AND DIMENSIONALLY AND MET ALL SPECIFICATIONS. THE THERMISTOR RESISTANCE VALUE WAS WITHIN THE SPECIFIED RANGE AND THE PROBE PASSED ALL THE STANDARD ELECTRICAL FINAL RELEASE TESTS. THE PLUG SHAFT LENGTH AND DIAMETER WERE VERIFIED TO BE WITHIN TOLERANCE. THERE ARE SEVERAL FACTORS ASSOCIATED WITH MAINTAINING TEMPERATURE IN A WARMER - THE SKIN TEMPERATURE PROBE, THE CONTACT BETWEEN THE PROBE AND THE INFANT'S SKIN, THE USE OF A REFLECTIVE COVER TO INSULATE AND SECURE THE PROBE TIP, THE CONDITION OF THE SOCKET OF THE WARMER AND WARMER CALIBRATION AND PREVENTATIVE MAINTENANCE. WE HAVE BEEN UNABLE TO GET DEFINITIVE INFO ON ANY OF THE OTHER FACTORS. TARRY MEDICAL PRODUCTS IS REPORTING THIS INCIDENT TO BE CAUTIOUS AS WE CANNOT DEFINITIVELY RULE OUT WHETHER OR NOT THE PROBE CONTRIBUTED TO THE INCIDENT.