MAUDE Adverse Event Report: LAERDAL MEDICAL A/S LAERDAL DISPOSABLE PEEP VALVE ASSEMBLY

Catalog Number 845040

Device Problems Complete Blockage (1094); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problems Respiratory Distress (2045); Obstruction/Occlusion (2422)

Event Date 05/01/2015

Event Type  malfunction  

Manufacturer Narrative

Following this event the user inspected the equipment and found the peep valve was stuck/clogged with patient secretions.They disposed of this valve and it was not available for return to the manufacturer.This lsr and peep valve had been used repeatedly on this one patient throughout the week.They did not report doing any pre-use functional testing of the lsr and/or peep during this week.The peep valve is labeled as a single patient use product.No corrective action is recommended.

Event Description

Laerdal medical (b)(4) has informed laerdal medical corporation (lmc) in (b)(4) of an event which occurred in (b)(6).In (b)(6) 2015 a male patient with pneumonia, who had been in the hospital 6-7 days, was intubated and had been mechanically ventilated when they were to be manually ventilated with a laerdal silicon resuscitator (lsr) and peep valve.The lsr was used and the nurse noticed the patient was not exhaling and they promptly removed the lsr and used other ventilation.This lsr w/peep valve had been used on this patient off and on for the entire week.The patient was not harmed during this event.The patient's final outcome is unknown.

• Brand Name: LAERDAL DISPOSABLE PEEP VALVE ASSEMBLY
• Type of Device: PEEP VALVE
• Manufacturer (Section D): LAERDAL MEDICAL A/S; 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: 4926063
• MDR Text Key: 22382689
• Report Number: 9610483-2015-00001
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K981415
• 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: 07/16/2015,06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 845040
• Device Lot Number: 021214
• 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: 07/16/2015
• Distributor Facility Aware Date: 06/18/2015
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention