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

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.

• Brand Name: SPUR II
• Type of Device: MANUAL 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 Key: 8231930
• MDR Text Key: 132545765
• Report Number: 9610961-2019-00001
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K152931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• 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 Received: 01/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2020
• Device Catalogue Number: 325002002
• Device Lot Number: 1000060589
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/28/2018
• Event Location: Hospital
• Date Manufacturer Received: 12/13/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Death