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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LAERDAL MEDICAL A/S LAERDAL SUCTION UNIT (LSU); PORTABLE SUCTION UNIT
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LAERDAL MEDICAL A/S LAERDAL SUCTION UNIT (LSU); PORTABLE SUCTION UNIT Back to Search Results
Model Number 780020
Device Problems Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 06/29/2015
Event Type  malfunction  
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.
 
Event Description
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.
 
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.
 
Event Description
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.
 
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Brand Name
LAERDAL SUCTION UNIT (LSU)
Type of Device
PORTABLE SUCTION UNIT
Manufacturer (Section D)
LAERDAL MEDICAL A/S
tanke svilandsgate 30
stavanger, rogaland N-400 2
NO  N-4002
Manufacturer (Section G)
LAERDAL MEDICAL CORPORATION
167 myers corners road
p.o. box 377
wappingers falls NY 12590 8840
Manufacturer Contact
donald garrison
167 myers corners road
wappingers falls, NY 12590-8840
8452977770
MDR Report Key4960979
MDR Text Key22379943
Report Number9610483-2015-00002
Device Sequence Number1
Product Code BTA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K993668
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial
Report Date 07/30/2015,06/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Device Unattended
Device Model Number780020
Device Catalogue Number78001007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/30/2015
Distributor Facility Aware Date06/30/2015
Device Age8 YR
Event Location Other
Date Report to Manufacturer07/30/2015
Date Manufacturer Received07/17/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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