MAUDE Adverse Event Report: WAISMED LTD NIO ADULT; INTRAOSSEOUS ACCESS DEVICE FOR ADULTS

Model Number	NIO-A
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint description from customer on march 30 2025: "patient was in cardiac arrest with cpr being performed.Crew arrived, took over cpr.Iv was attempted and failed.Nio was brought out, site located and when we spun the top on the nio to unlock it, it was tight to turn.Pressure placed with dominant hand, other hand stabilizing nio.Nio did not deploy, second crewmember attempted to deploy it and it did not work.Second nio was brought out and the same thing happened.Top was tight to spin and it did not deploy for either the rn or emt.Manual io was placed in this patient first attempt.Cpr continued.Patient died.One of the nio that did not deploy was brought back to the station and is currently being sent back with the provided shipping label.
Additional Manufacturer Narrative
There were two medicinal devices involved in this report.One medical device only remain in user hands, which has been requested to be returned to manufacturer site to perform an engineering investigation.

• Brand Name: NIO ADULT
• Common Device Name: INTRAOSSEOUS ACCESS DEVICE FOR ADULTS
• Manufacturer (Section D): WAISMED LTD; 10 amal st; afek industrial park; rosh ha'yin 4809234
• Manufacturer (Section G): WAISMED LTD; afek industrial park; rosh ha'yin 4809234.; IS
• Manufacturer Contact: giovani munoz ; 10 amal st; afek industrial park; rosh ha'yin 4809234, ; IS
• MDR Report Key: 21750879
• Report Number: 9616791-2025-00002
• Device Sequence Number: 8235553
• Product Code: FMI
• UDI-Device Identifier: 07290008325059
• UDI-Public: 07290008325059
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K142086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NIO-A
• Device Catalogue Number: NIO-A
• Device Lot Number: 2440043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 77 KG