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

Model Number	520611000
Medical Device Problem Codes	Inflation Problem (1310); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Respiratory Failure (2484)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A final report and conclusion will be submitted when the device has returned to the manufacture and investigated.
Event or Problem Description
Ambu bag deflated and unable to get the resuscitator to expand correctly to be able to deliver an adequate flow.The health professionals utilized another ambu bag.Patient did not survive the code.According to health care professional the patient's demise was not related to the poor performance of the ambu bag, but rather due to comorbidities and a hgb of 5.
Event or Problem Description
Ambu bag deflated and unable to get the resuscitator to expand correctly to be able to deliver an adequate flow.The health professionals utilized another ambu bag.Patient did not survive the code.According to health care professional the patient's demise was not related to the poor performance of the ambu bag, but rather due to comorbidities and a hgb of 5.
Additional Manufacturer Narrative
Update to mdr submitted february 17, 2023.No correction to data.Updated based on investigation findings: 5 samples was returned for investigation.Four in original packing and one unpacked.All bags was found to be dented.Dented bag could support the report failure.Delivered volume test was performed on the samples.Test results show that four samples failed the test but one sample passed even though it was dented.The products was packed and controlled according to working instructions.Visual inspection was performed on the products during production and 100 % function test was performed during the production line.The resuscitators are packed into a carboard box according to work instruction and 100% visual inspection is performed on the package before delivery.The reported products should therefore be within specificaitons when shipped.The reported issue of the bag being collapsed and unable to re-inflate is suspected to be due to storage of the product in a compressed state at the customer which could cause the dents in the bag.As stated in the accompanying ifu, the resuscitator should never be stored in a deformed stated as permanent distortion of the bag may reduce the ventilation efficiency.According to the health care professional patient died was not related to the performance of the device but rather to the patient's condition.Even though there is no causality implied between patient outcome and device malfunciton the mdr is submitted since patient died.

• Brand Name: AMBU SPUR II ADULT RESUSCITATOR
• Common Device Name: AMBU SPUR II ADULT RESUSCITATOR
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU LTD.; room b401, 4th floor b area; no. 31, xinghu rd.; xiamen, hu li district, ; CH
• Manufacturer Contact: kristine rasmussen ; baltorpakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 16395786
• Report Number: 9610691-2023-00007
• Device Sequence Number: 6375716
• Product Code: BTM
• UDI-Device Identifier: 05707480151776
• UDI-Public: 5707480151776
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K152931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 520611000
• Device Catalogue Number: 520611000
• Device Lot Number: 1000627858
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown