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

Model Number SO-430

Device Problem Connection Problem (2900)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

This would delay the treatment for the patient.

Event Description

The reservoir bag disconnected from the mask.

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 Description

The reservoir bag disconnected from the mask.

• Brand Name: SALTER LABS
• Type of Device: 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
• MDR Text Key: 328899849
• Report Number: 3000219639-2023-00039
• Device Sequence Number: 1
• Product Code: KGB
• UDI-Device Identifier: 00607411800849
• UDI-Public: 00607411800849
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SO-430
• Device Catalogue Number: SO-430
• Device Lot Number: 383193
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other