MAUDE Adverse Event Report: SALTER LABS SALTER LABS; MASK, ADULT, OXYGEN, HIGH CONCENTRATION, NON-REBREATHING

Model Number	SO-430
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This would delay the treatment for the patient.
Event or Problem Description
The reservoir bag disconnected from the mask.
Additional Manufacturer Narrative
This would delay the treatment for the patient.Complaint history reviewed.There have been 3 similar complaints in the previous 24 months for senko product.Senko product is manufactured as separate lot and not mixed with other material.Dhr review shows product passed sampling plan.Quality alert generated and training completed during the investigation with the multifunctional team, determined the root cause, and implemented the following corrective and preventative actions.Root cause: 1 operator performed manual assembly of the bag, tape and grommet 2 the operator did not detect that the tape and bag were assembled correctly during the assembly and packaging of the finished product.Corrective actions: 1 updated ai-700041 format to clarify placement of tape and bag in grommet.Dcr-13514 2 feedback was provided to line 6 personnel on the proper assembly of bags and grommet.Risk:(rma-20017a) r26: oxygen delivery interrupted - cannula components not bonded together securely - s=8 o=3 irpn=24 has a severity of (8/10) which meets the threshold of (8/10) for carb review.
Event or Problem Description
The reservoir bag disconnected from the mask.

• Brand Name: SALTER LABS
• Common Device Name: MASK, ADULT, OXYGEN, HIGH CONCENTRATION, NON-REBREATHING
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18196863
• Report Number: 3000219639-2023-00039
• Device Sequence Number: 15297137
• Product Code: KGB
• UDI-Device Identifier: 00607411800849
• UDI-Public: 00607411800849
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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: SO-430
• Device Catalogue Number: SO-430
• Device Lot Number: 383193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown