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U.S. Department of Health and Human Services

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

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AMB U A/S SPUR II MANUAL RESUSCITATOR Back to Search Results
Catalog Number 325002002
Device Problems Material Puncture/Hole (1504); Component Missing (2306)
Patient Problem Death (1802)
Event Date 12/04/2018
Event Type  Death  
Manufacturer Narrative
Device not returned for investigation. Per customer description the facemask was missing from the resuscitator bag. Spur ii is packed as per work instruction. An electronic scale is included in production line to weigh each product before packaging. Deviation of weigh will indicate missing components. Qc records includes both result of weigh of each device and quantity of components used in production of the lot. Qc records has been checked an no deviations found. When the resuscitator bag is placed into carton boxes a cardboard cover is placed on top of the resuscitator with the facemask connector going through a hole in the lid. Facemask missing would most likely be detected during production either when weighing the product or when the carton box is packed due to the placement of the facemask connector in the hole of the lid. According to ifu the resuscitator shall when being placed ready for use be prepared by performing the following steps: if the resuscitator is packed in a compressed state, unfold by pulling on the patient valve and the inlet valve. If the facemask supplied with the resuscitator is wrapped in a protective pouch, the pouch should be remove before use. Fit the facemask and place all items in the plastic bag supplied with the resuscitator. The integrity of the kits issued for storage ready for use should be inspected at the interval established in the local protocol. Before use on the patient make a brief functional test as described in section 7 (of the ifu). The following caution is included in the ifu: always inspect the resuscitator and perform a functional test after unpacking, cleaning, assembly and prior to use. Switch immediately to mouth-to-mouth ventilation if efficient ventilation cannot be obtained. According to customer the resuscitator was placed on a resuscitator trolley. The resuscitator is supposed to be ready for use when placed on a resuscitator trolley. Either the spur ii was not placed ready to use or the facemask was removed afterwards. The placement of the initial resuscitator in two non-ambu bags and the second resuscitator in a teared bag with an untampered seal could indicate removal of facemask from resuscitator trolley. Fault is included in the product risk analysis. The current report does not result in a change of the risk assessment. No causal relationship has been established between missing facemask and patient's death. Patient was in cardiac arrest when the resuscitator was fetched. The underlying condition of the patient is unknown. It is not clear if the facemask was removed from the resuscitator carrying back after it was placed on the resuscitator trolley. It is highly unlikely that a missing facemask would not be found at the manufacturing site either when the resuscitator is weighed during production or when packed. The incident is reported due to the following: patient died (patient was in cardiac arrest and resuscitation was unsuccessful). Device allegedly malfunctioned (facemask missing from pouch being placed ready for use).
 
Event Description
Spur ii was used during a cardiac arrest. Facemask found to be missing from pouch. After review of resuscitators throughout the acute hospital site the following day the customer found another spur ii (same lot no. ) without a facemask. According to information received from customer the initial spur ii was found to be placed in two plastic bags, none of them being the ambu packaging. The second spur ii alleged not having a facemask was found in an ambu resuscitator bag with a big hole torn on the side and with the seal untampered.
 
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Brand NameSPUR II
Type of DeviceMANUAL RESUSCITATOR
Manufacturer (Section D)
AMB U A/S
baltorpbakken 13
ballerup, dk 2750
DA 2750
Manufacturer (Section G)
AMBU INC
6230 old dobbin lane
suite 250
columbia MD 21045
Manufacturer Contact
sanjay parikh
6230 old dobbin lane
suite 250
columbia, MD 
4107686464
MDR Report Key8231930
MDR Text Key132545765
Report Number9610961-2019-00001
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K152931
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/12/2020
Device Catalogue Number325002002
Device Lot Number1000060589
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/28/2018
Event Location Hospital
Date Manufacturer Received12/13/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/09/2019 Patient Sequence Number: 1
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