MAUDE Adverse Event Report: LINDE GAS & EQUIPMENT INC. LIV (LINDE INTEGRATED VALVE); CYLINDER, COMPRESSED GAS, AND VALVE

Device Problem Material Integrity Problem (2978)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Respiratory Arrest (4461)

Event Date 03/16/2022

Event Type  malfunction  

Event Description

Patient on medical stepdown unit had rapid response called for hypotension and oxygen desaturations.Decision made to transfer patient to icu.As staff were preparing to transfer the patient, they switched the patient from the wall oxygen supply to an liv (linde integrated valve) portable oxygen tank.Staff turned the top valve on, heard a release of air, and thought oxygen was flowing.Within a minute or so, the patient's oxygen saturations dropped to the 50s.The patient went into cardiorespiratory arrest, cpr was started, and code blue was activated.Once rosc (return of spontaneous circulation) achieved, the rn checked o2 tank and found the second valve (the one that turns the oxygen on and off) which is located on the side of the tank was in the "off" (red) position.The linde liv integrated valve oxygen system (portable oxygen tank with regulator) has 2 valves.The regulator valve is on top and on/off valve is on the side.Both valves need to be open for oxygen to flow.When you open the top valve, there is a hissing noise which can mislead the user into thinking that the oxygen is flowing and fully turned on.Subsequently, they may not open the side valve because they think the oxygen is already "on." we have had a number of near misses since this tank was introduced to our hospital in (b)(6) 2017.We believe the design of this tank presents a serious safety concern.

• Brand Name: LIV (LINDE INTEGRATED VALVE)
• Type of Device: CYLINDER, COMPRESSED GAS, AND VALVE
• Manufacturer (Section D): LINDE GAS & EQUIPMENT INC.; 145 shimersville rd.; bethlehem PA 18015
• MDR Report Key: 13844674
• MDR Text Key: 287618523
• Report Number: 13844674
• Device Sequence Number: 1
• Product Code: ECX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Sex: Female
• Patient Weight: 117 KG
• Patient Race: Black Or African American