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U.S. Department of Health and Human Services

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

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AMBU A/S SPUR II ADULT RESUSCITATOR MANUAL RESUSCITATOR, Back to Search Results
Catalog Number 522611000
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2021
Event Type  Death  
Manufacturer Narrative
A part of the spur ii was reported to be missing. This resulted in insufficient resuscitation of a patient. The patient died. No sample was returned for investigation. Per confirmation by the customer, the reported issue was that the outlet connector on the patient valve was missing due to a use error. Someone had removed expiratory/outlet connector at customer side in order to use it with another spur ii resuscitator. The reported product was manufactured and controlled in accordance with the working instructions. 100% visual inspection and 100% function testing is performed on spur ii to make sure the product is performing as specified when delivered to the customer. It is stated in the instructions for use that a functionality precheck should always be performed before using the product on a patient. Had this been done, the user would have discovered that a piece was missing and other means of resuscitation could have been used in stead.
 
Event Description
Patient was not receiving adequate ventilation during code blue resuscitation event. It was identified that the ambu bag was missing the white screw in pressure limiting cap. The cap is designed to be removable to allow user to clear the valve chamber. The pressure limiting cap should never be removed during operation. A use error was made. It was stated by an employee at the health care facility that someone had decided to take a piece from the device to use with another resuscitator. The user complained that the packaging of the spur can be opened and closed and still appear untouched. It wasn't realised by the user that there was a piece missing before it was too late for the patient. The patient died. The prescribed precheck was not performed in accordance with the instructions for use. If a precheck had been made, the missing piece would have been identified and other means of resuscitation could have been used.
 
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Brand NameSPUR II ADULT RESUSCITATOR
Type of DeviceMANUAL RESUSCITATOR,
Manufacturer (Section D)
AMBU A/S
baltorpbakken 13
ballerup, 2750
DA 2750
Manufacturer Contact
nina skjoldborg
baltorpbakken 13
ballerup, 2750
DA   2750
MDR Report Key11841621
MDR Text Key251226293
Report Number9610691-2021-00006
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
PMA/PMN Number
K152931
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number522611000
Device Lot Number1000422792
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/18/2021 Patient Sequence Number: 1
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