FDA Adverse Event Injury Summary report: N

PNEUPAC PARAPAC

MDR report key: 2931417 · Received January 3, 2013

Report

Report Number: 2183502-2012-00653
Event Type: Injury
Date Received: January 3, 2013
Date of Event: October 23, 2012
Report Date: January 2, 2013
Manufacturer: SMITHS MEDICAL INTERNATIONAL LTD.
Product Code: BTL
PMA / PMN Number: K020899
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A VOLUNTARY REPORT WAS RECEIVED VIA THE US MAIL. THE COVER PAGE FOR THE REPORT STATED: THE REPORT, (B)(4), WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. WE ARE FORWARDING IT TO YOU FOR REVIEW SINCE YOU MIGHT BE UNAWARE OF THIS EVENT. THE MFR CONTACTED THE INITIAL REPORTER ON (B)(4) 2012 FOR ADDITIONAL INFO. NO FURTHER INFO HAS BEEN FORTHCOMING. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVAL BY THE MFR. THIS INFO IS BEING ENTERED INTO THE COMPLAINT SYSTEM FOR TRACKING AND REPORTING PURPOSES.

Description of Event or Problem · 1

RECEIVED NOTICE FROM FDA REGARDING AN INCIDENT. EVENT DESCRIPTION IS AS FOLLOWS: VOLUN (B)(6) 2012: UNRESPONSIVE, INTUBATED PT HAD JUST BEEN TRANSFERRED FROM CT TABLE TO ED GURNEY WHEN A LOUD POP WAS HEARD AND FLAMES APPEARED OVER THE PT'S RIGHT THIGH REGION. EQUIPMENT IN USE AT THE TIME OF THE HEAD CT INCLUDED A PORTABLE VENTILATOR WITH OXYGEN FEED, A SLIDER BOARD TO ASSIST WITH PT TRANSFER FROM CT TABLE TO GURNEY, AND A BAIR HUGGER BLANKET WHICH WAS NOT ATTACHED TO THE BAIR HUGGER WARMING DEVICE. THE OXYGEN SOURCE WAS TERMINATED AT THE SAME TIME THE FIRE WAS IMMEDIATELY EXTINGUISHED, AND PT WAS HAND-VENTILATED. THE PT SUSTAINED A PARTIAL THICKNESS BURN TO HER RIGHT THIGH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
3719	PNEUPAC PARAPAC	BTL - VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)	BTL	SMITHS MEDICAL INTERNATIONAL LTD.	120003	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention