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U.S. Department of Health and Human Services

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

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AMBU A/S AMBU SPUR II MANUAL RESUSCITATOR Back to Search Results
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.
 
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Brand NameAMBU SPUR II
Type of DeviceMANUAL RESUSCITATOR
Manufacturer (Section D)
AMBU A/S
baltorpbakken 13
ballerup, 2750
DA 2750
Manufacturer (Section G)
AMBU A/S
baltorpbakken 13
ballerup, 2750
DA 2750
Manufacturer Contact
katrine ajbro
baltorpbakken 14
ballerup, 2750
DA   2750
MDR Report Key12120136
MDR Text Key259980810
Report Number9610691-2020-00005
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152931
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
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 Received07/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number520211000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2020
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

Patient Treatment Data
Date Received: 07/06/2021 Patient Sequence Number: 1
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