MAUDE Adverse Event Report: LINDE GAS & EQUIPMENT GRAB N' GO; GRAB 'N GO DIGITAL

Model Number	MVA2UOS011
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was evaluated, and functional testing was performed in accordance with established procedures.The evaluation confirmed that the regulator transitions into and out of fill mode as designed and that no leaks or functional abnormalities were identified.Based on the results of the evaluation and review of the available information, the device was found to be operating within specification at the time of testing.The reported condition, in which the regulator was observed in fill mode during use, is consistent with inadvertent activation of the fill mode control during handling or operation.No device malfunction was identified that would have contributed to the reported event.
Event or Problem Description
(e)(1) reported that a patient receiving supplemental oxygen from a portable oxygen cylinder equipped with a grab n' go regulator.The regulator was reportedly set to deliver oxygen at 4 l/min.During use, the cylinder indicated it was in fill mode, and the pressure indicator displayed approximately 43 psi.No audible alarm was triggered.The patient was observed to have decreased oxygen saturation to 83% and was reported to be hypoxic.In response, oxygen therapy was increased to 6 l/min via nasal cannula, resulting in the patient vitals returning to pre-event levels.

• Brand Name: GRAB N' GO
• Common Device Name: GRAB 'N GO DIGITAL
• Manufacturer (Section D): LINDE GAS & EQUIPMENT; 10 riverview drive; danbury CT
• Manufacturer (Section G): LINDE GAS & EQUIPMENT; 10 riverview dr; danbury CT 06810
• Manufacturer Contact: dave loflin ; 10 riverview drive; danbury, CT 06810
• MDR Report Key: 24998284
• Report Number: 3012160128-2026-00005
• Device Sequence Number: 15896096
• Product Code: ECX
• UDI-Device Identifier: 00850009834102
• UDI-Public: 00850009834102
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K132778
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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: MVA2UOS011
• Device Catalogue Number: OX M-AEGNGDIGIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OXYGEN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown