MAUDE Adverse Event Report: LAERDAL MEDICAL A/S LAERDAL SUCTION UNIT (LSU); PORTABLE SUCTION UNIT

Model Number 780020

Device Problem Thermal Decomposition of Device (1071)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

On may 5th 2016 a fire inspector visited the scene and conducted an inspection of the ambulance and its equipment.They provided preliminary photos to laerdal and are completing their cause & origin report.The photos show about half of the laerdal suction unit's case was melted in this fire.It appears the lsu was stored in a carry bag, placed on a metal rack in the ambulance, and connected to an interior duplex 110vac outlet via an ac power cord for charging of its battery.Other equipment (possibly powered) appear to have been on this metal storage rack at the time of the fire, but they have not been identified.Laerdal has made requests to the insurance companies to be able to evaluate this damaged lsu.The cause of the ambulance fire is unkown at this time.

Event Description

Laerdal received a "notice of claim and inspection" letter on apr 28, 2016 from an insurance company stating a lsu was involved in an ambulance fire, which occurred on (b)(6) 2016 and involved property damage.When called on apr 29, 2016, the director of operations of the ambulance company reported that someone at the station noticed smoke and moved the parked ambulance outside the ambulance bay where the fire was extinguished.Fire damages appeared isolated to the interior of the ambulance and its equipment.

• 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; wappingers falls NY 12590 8840
• Manufacturer Contact: donald garrison ; 167 myers corners road; wappingers falls, NY 12590-8840 ; 8452977770
• MDR Report Key: 5667924
• MDR Text Key: 45574018
• Report Number: 9610483-2016-00001
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2016,04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Device Unattended
• Device Model Number: 780020
• Device Catalogue Number: 78002001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2016
• Distributor Facility Aware Date: 04/28/2016
• Device Age: 8 YR
• Event Location: Other
• Date Report to Manufacturer: 05/19/2016
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1