LAERDAL SUCTION UNIT (LSU)
Received Jul 30, 2015 · Event occurred Jun 29, 2015
Report 9610483-2015-00002 · MDR key 4960979
Device
Generic name
Portable Suction Unit
Manufacturer
Laerdal Medical A/sModel number
780020Catalog number
78001007
Product problems
- Thermal Decomposition of Device
- Electrical /Electronic Property Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
INITIAL PAPER MDR WAS MAILED TO FDA ON (B)(4) 2015. AN ELECTRONIC FOLLOW-UP WAS ATTEMPTED BUT WAS NOT ACCEPTED ON (B)(4) 2015. THIS ELECTRONIC SUBMISSION INCLUDES ALL INITIAL AND FOLLOW-UP MDR DATA - SUBMITTED AS A FOLLOW-UP TO MDR #9610483-2015-00002. (B)(4) 2015 INITIAL: THE LSU AND THE LSU WALL BRACKET WERE RETURNED TO LAERDAL MEDICAL A.S. FOR EVALUATION ON (B)(4) 2015. TESTING OF THE AMBULANCE'S POWER SOURCE(S), WIRING AND VOLTAGE CONVERTORS HAS BEEN REQUESTED. (B)(4) 2015 FOLLOW-UP: EVALUATION: THE RETURNED LAERDAL SUCTION UNIT (LSU) AND LSU WALL BRACKET WERE EVALUATED BY LAERDAL MEDICAL AS. AN INDEPENDENT INSPECTOR HAS EXAMINED THE GENERATOR USED BY THIS FRENCH AMBULANCE COMPANY TO POWER THEIR AMBULANCES WHILE PARKED. THE FACILITY'S GENERATOR WAS FOUND TO BE OPERATING ERRATICALLY WITH ITS 240VAC OUTPUT VARYING BETWEEN 100 AND 400 VAC. THE FACILITY HAS REMOVED THIS EXTERNAL GENERATOR FROM SERVICE. CONCLUSION: THE ERRATIC OVER-VOLTAGE FROM THE FACILITY'S GENERATOR CAUSED A VOLTAGE SURGE SUPPRESSION VARISTOR COMPONENT (LOCATED ON LSU POWER BOARD) TO OVERHEAT AND BURN A SMALL PORTION OF THE LSU AND LSU WALL BRACKET SURROUNDING ITS EXTERNAL AC INPUT POWER SOCKET. THE BURNING WAS LOCALIZED TO THE LSU AND WALL BRACKET AND THE AMBULANCE INTERIOR WAS ONLY EXPOSED TO SMOKE/SOOT. THE MAXIMUM CONTINUOUS EXTERNAL AC INPUT SPECIFIED FOR THE LAERDAL SUCTION UNIT IS 264VAC AND THE VARISTOR IS RATED FOR MAXIMUM CONTINOUS INPUT OF 275 VAC(RMS). DUE TO THIS FACILITY POWER FAILURE THE LAERDAL SUCTION UNIT WAS EXPOSED TO AN EXTERNAL AC POWER INPUT THAT WAS WELL BEYOND ITS SPECIFIED POWER LIMITS. NO FAULTS WERE FOUND WITH THE LSU.
Description of Event or Problem
A LAERDAL SUCTION UNIT (LSU) WAS PLUGGED INTO A LAERDAL WALL BRACKET FOR CHARGING INSIDE AN AMBULANCE IN (B)(6). THE AMBULANCE HAD BEEN PARKED (WITH ONLY LSU AND RADIO ALWAYS POWERED) AT A RESCUE CENTER FOR ABOUT 4 DAYS WHEN A FIRE BEGAN NEAR THE LSU. FIREMEN QUICKLY EXTINGUISHED THE FIRE AND NO ONE WAS HARMED. THE LSU HAD A SECTION OF ITS CASE MELTED AWAY AND ITS BATTERY WAS HEAVILY DAMAGED.
Additional Manufacturer Narrative
THE LSU AND THE LSU WALL BRACKET WERE RETURNED TO LAERDAL MEDICAL (B)(6) FOR EVALUATION ON JULY 17, 2015. TESTING OF THE AMBULANCE'S POWER SOURCE(S), WIRING AND VOLTAGE CONVERTERS HAS BEEN REQUESTED.
Description of Event or Problem
A LAERDAL SUCTION UNIT (LSU) WAS PLUGGED INTO A LAERDAL WALL BRACKET FOR CHARGING INSIDE AN AMBULANCE IN (B)(6). THE AMBULANCE HAD BEEN PARKED (WITH ONLY LSU AND RADIO ALWAYS POWERED) AT A RESCUE CENTER FOR ABOUT 4 DAYS WHEN A FIRE BEGAN NEAR THE LSU. FIREMEN QUICKLY EXTINGUISHED THE FIRE AND NO ONE WAS HARMED. THE LSU HAD A SECTION OF ITS CASE MELTED AWAY AND ITS BATTERY WAS HEAVILY DAMAGED.