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

Model Number ADULT

Device Problems Use of Device Problem (1670); Blocked Connection (2888); Device Handling Problem (3265)

Patient Problems Overinflation of Lung (2397); Low Oxygen Saturation (2477)

Event Date 10/02/2014

Event Type  malfunction  

Event Description

Laerdal medical (b)(4) has informed laerdal medical corporation (lmc) in new york of any event which occurred in (b)(6).On (b)(6), child was admitted to the hospital's picu and after a sudden drop in spo2 was intubated and ventilated.A new the bag ii disposable resuscitator was connected to oxygen (>16l/min flow) and attached to the patient's et tube.A nurse verified the resuscitator setup was initially ok.The doctor heard the excess oxygen venting out the back of the resuscitator and the nurse touched the open o2 overpressure umbrella valve thereby blocking the oxygen exhaust port.During this user blockage event, the resuscitator bag and patient airway became pressurized by the oxygen.The doctor noticed the patient's lungs were inflated and removed the resuscitator to relieve this pressure.No reports of injury to this child were received and their final outcome is unknown.

Manufacturer Narrative

The customer disposed of this resuscitator and it was not available for return to the manufacturer.The hospital staff was only able to recreate this overpressure condition on other the bag iis using a sealed test lung with >15 l/min flow of oxygen and then momentarily blocking the o2 overpressure valve.At lower o2 flows the overpressure condition would not occur.Squeezing the resuscitator bag would release this pressure and return the bag ii resuscitator to normal operation.No faults were found with the bag ii resuscitators either before or after this user blockage event.The o2 overpressure valve was not sticking or binding in a closed position - the user was intentionally pressing the o2 overpressure valve closed.The resuscitator dfu states an oxygen flow of 10 l/min is sufficient for >99% oxygen concentration in an adult.By design, the external o2 overpressure valve is recessed and protected from casual blockages.No corrective action is recommended.

• 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; p.o. box 377; stavanger N-40 02; NO N-4002
• Manufacturer Contact: don garrison ; 167 myers corner rd; wappingers falls, NY 12590 ; 8452977770
• MDR Report Key: 4236622
• MDR Text Key: 19762635
• Report Number: 9610483-2014-00003
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2014,10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADULT
• Device Catalogue Number: 845041
• Device Lot Number: 040314
• 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: 10/31/2014
• Distributor Facility Aware Date: 10/04/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 29