MAUDE Adverse Event Report: LAERDAL MEDICAL A.S. OF STAVANGER LAERDAL SILICON RESUSCITATOR (LSR); MANUAL REUSABLE RESUSCITATOR

Model Number ADULT

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems Cardiac Arrest (1762); Pneumothorax (2012); Low Oxygen Saturation (2477)

Event Date 05/01/2014

Event Type  Injury  

Event Description

Laerdal medical a.S.(lmas) in (b)(6) has informed laerdal medical corporation (lmc) in (b)(6) of an event which occurred in (b)(6).A female hospital patient in preparation for a thyroidectomy operation began coughing.She was being manually ventilated with oxygen through a laerdal silicone resuscitator (lsr) while the anesthesia machine was prepared.Her oxygen saturation decreased over a 2 minute time period and she went into asystole.The lsr was removed from the patient and a large air flow / exhale occurred.Cpr was provided for about one minute and circulation returned.A thorax and abdomen ct scan confirmed pneumothorax in both lungs.The patient survived this event.

Manufacturer Narrative

This lsr was returned to lmas and it passed all inspections and functional tests and meets all specifications.An over pressure condition could be created if oxygen was connected to the lsr and it had the old style of lsr intake valve (pre 2003); no external lsr reservoir valve was connected; and the 23 mm od lsr intake port then blocked/occluded.This over pressure condition could be relieved by delivering one, or more, lsr ventilations or opening/venting the bag/airway conduit.The lsr dfu recommends using the lsr reservoir valve and oxygen reservoir to deliver higher oxygen concentrations.The lsr oxygen reservoir will not connect to the lsr without the reservoir valve.With the lsr reservoir valve connected this condition could not have occurred.The current lsr configuration (since 2003) is not susceptible to this unusual user error.Unusual occurrence.We have little detail of user's equipment configurations during this event.

• Brand Name: LAERDAL SILICON RESUSCITATOR (LSR)
• Type of Device: MANUAL REUSABLE RESUSCITATOR
• Manufacturer (Section D): LAERDAL MEDICAL A.S. OF STAVANGER; stavanger ; NO
• Manufacturer (Section G): LAERDAL MEDICAL A.S.,; p.o. box 377; n-4002; stavanger ; NO
• Manufacturer Contact: don garrison ; 167 myers corners road; wappingers falls, NY 12590 ; 8452977770
• MDR Report Key: 3918863
• MDR Text Key: 16858989
• Report Number: 9610483-2014-00002
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/25/2014,05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ADULT
• Device Catalogue Number: 870000
• Device Lot Number: 080403
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2014
• Distributor Facility Aware Date: 05/27/2014
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2014
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2003
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR