MAUDE Adverse Event Report: AMBU A/S AMBU SPUR II; MANUAL RESUSCITATOR

Catalog Number 520211000

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2020

Event Type  Death  

Manufacturer Narrative

The patient presented in asystole upon arrival of the ambulance and never changed rhythm.A causal relationship between the pediatric spur ii product provided in an adult package and patient outcome has not been established.The pediatric spur ii was never used on the patient.However, ambu does not have data to establish that the root cause of the event is solely due to patient condition.No samples have been returned to ambu, but pictures from the customer of the labels on the final packaging and of the spur ii products have been sent to ambu.The pictures confirmed the reported failure (pediatric spur ii packed in bag labelled as adult).Based on the provided lot number on the pediatric spur ii and the packaging, the production records have been checked.As there is approximately 6 years between the manufacturing date of the spur ii and the manufacturing date of the final packaging , it is considered unlikely that the final packaging is packed wrongly in ambu production line due to so long time off between each other.In addition, all spur ii in their final packaging are subject to both visual inspection and a check by weighing prior to release.The weight difference between adult bag and pediatric bag can be detected by the electronic scale.

Event Description

Provider called for cardiac arrest and patient presented in asystole.A provicer grabbed a bag-valve-mask (bvm) for ventilation and realized pediatric sized bvm was in an adult labeled package, patient had no rhythm changes.The pediatric sized bvm was not used.The patient presented in asystole upon arrival at hospital and never changed rhythm.

• Brand Name: AMBU SPUR II
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 12120136
• MDR Text Key: 259980810
• Report Number: 9610691-2020-00005
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• PMA/PMN Number: K152931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 520211000
• Date Manufacturer Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention