MAUDE Adverse Event Report: SALTER LABS SALTER LABS; MULTIFUNCTION CONCENTRATOR INDICATOR

Model Number PRO2ELITE-1

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2023

Event Type  malfunction  

Event Description

The end user experiencing a bent tube. .

Manufacturer Narrative

The indicator giving incorrect reads due to bent tubing would impact the therapy of the "patient.".

Manufacturer Narrative

The indicator giving incorrect reads due to bent tubing would impact the therapy of the patient.The complaint investigation was performed based on the content of the issue reported.There was no physical returned product, however, the photo image was provided and confirmed the bent tube.There was no lot number provided; therefore, the device history record (dhr) review was unable to be conducted.A root cause could not be identified but a possible cause may have been due to handling or storing of the product.We will continue to monitor trends during our periodic complaint review meetings.Based on rma-20019 rev 1, pro2, product risk analysis under the known and foreseeable hazards "connecting tubing kink" id r5 was identified.The potential cause(s) of hazard (hazardous situation) "tube twisting" 4 = severity, 2 = likelihood of occurrence, rpn is 8; therefore, the risk level is acceptable.Based ref-20001-c1 rev 1 in table 1a, the risk is low.The regulatory / compliance risk is low.

Event Description

The end user experiencing a bent tube. .

• Brand Name: SALTER LABS
• Type of Device: MULTIFUNCTION CONCENTRATOR INDICATOR
• 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: 18548341
• MDR Text Key: 333320707
• Report Number: 3000219639-2024-00004
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRO2ELITE-1
• Device Catalogue Number: PRO2ELITE-1
• Device Lot Number: UNKNONW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: No
• 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