MAUDE Adverse Event Report: LAERDAL MEDICAL A.S. THE BAG II DISPOSABLE RESUSCITATOR; MANUAL DISPOSABLE RESUSCITATOR

Catalog Number 845051

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem Cardiac Arrest (1762)

Event Date 01/01/2014

Event Type  No Answer Provided  

Event Description

Laerdal medical a.S.(lmas) in (b)(4) has informed laerdal medical corp.(lmc) in (b)(4) of an event which occurred in (b)(6) (event date and pt details not provided).Following a cardiac arrest, a the bag ii resuscitator was used to ventilate a non-breathing pt and connect them to portable oxygen.The 2 liter o2 tank was quickly emptied.Pt was intubated and the bag ii resuscitator was used to ventilate them.Oxygen from the ambulance was connected to the resuscitator at 15 l/min flow and the bag ii resuscitator's oxygen reservoir was only slightly inflated.The pt regained spontaneous breathing while in the ambulance.The pt's final outcome is unk.The bag ii resuscitator may have been leaking oxygen.The involved resuscitator was disposed of by the healthcare facility and not available for eval.

Manufacturer Narrative

The bag ii resuscitator dfu states for high oxygen concentrations, connect oxygen tubing and reservoir to resuscitator.Adjust the o2 flow to ensure the reservoir remains fully or partially inflated during use.For greater than 90% oxygen concentrations the oxygen flow must be at least 3 liters/minute for the adult model.A follow-up email to the initial reporter confirmed the resuscitator functioned properly and the cause of the oxygen leak was not known.

• Brand Name: THE BAG II DISPOSABLE RESUSCITATOR
• Type of Device: MANUAL DISPOSABLE RESUSCITATOR
• Manufacturer (Section D): LAERDAL MEDICAL A.S.; stavanger ; NO
• Manufacturer (Section G): LAERDAL MEDICAL A.S; po box 377; stavanger N-40 02; NO N-4002
• Manufacturer Contact: don garrison ; 167 myers corners road; wappingers falls, NY 12590 ; 8452977770
• MDR Report Key: 3872095
• MDR Text Key: 21719707
• Report Number: 9610483-2014-00001
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K021716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2014,05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 845051
• Device Lot Number: 240613
• 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: 05/29/2014
• Distributor Facility Aware Date: 05/14/2014
• Device Age: 10 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1