MAUDE Adverse Event Report: LAERDAL MEDICAL A/S LAERDAL SILICON RESUSCITATOR (LSR); MANUAL RESUSCITATOR

Model Number ADULT LSR

Device Problems Air Leak (1008); Detachment Of Device Component (1104); Device Handling Problem (3265)

Patient Problems Death (1802); Weakness (2145); Low Oxygen Saturation (2477); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The hospital reported they only have a few very old resuscitators that are used about 2-3 times per year.Based upon photos of the actual dis-assembled lsr involved in this event: this 2003 vintage lsr intake valve design was affected by a feb 2004 recall (2003-r-04, us fda z-517-4, market correction) where the intake valve and assembly (inner part w/ umbrella valve) was replaced by the current intake valve's inner part which uses a flat circular "ring" membrane intake valve.When expanding a stored collapsed lsr silicon bag with this old style inner part it was possible to contact and dislodge the umbrella intake valve - this is not possible on the current lsr inner part and membrane intake valve.This user was requested to dispose of all of their out-of-date lsr intake inner parts and replace then with current lsr intake valves.

Event Description

As reported from a hospital in (b)(6): an adult laerdal silicone resuscitator ( lsr) which had been stored compressed in a "case/toolbox" was used (event date unknown) on a hospitalized patient with breathing issues.When they went to use the lsr no ventilations could be provided because the inlet umbrella valve had been dislodged and was loose inside the silicone bag.The patient was later pronounced dead due to hypoxia (date/time unknown).There are no received medical claims that this loss of ventilation (obvious to user) caused any harm to this patient.

• Brand Name: LAERDAL SILICON RESUSCITATOR (LSR)
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): LAERDAL MEDICAL A/S; tanke svilandsgate 30; stavanger, N-400 2; NO N-4002
• Manufacturer (Section G): LAERDAL MEDICAL A/S; tanke svilandsgate 30; stavanger, N-400 2; NO N-4002
• Manufacturer Contact: donald garrison ; 167 myers corners road; wappingers falls, NY 12590-8840 ; 8452977770
• MDR Report Key: 7191939
• MDR Text Key: 97951525
• Report Number: 9610483-2018-00001
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/15/2018,12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADULT LSR
• Device Catalogue Number: 87005140
• Device Lot Number: 2903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2018
• Distributor Facility Aware Date: 12/18/2017
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2018
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-517-4 FROM 2004
• Patient Sequence Number: 1
• Patient Age: 92 YR