MAUDE Adverse Event Report: SALTER LABS SALTER LABS; PATIENT KIT - (1) #1215, AND (1) #2025 (AIR LIQUIDE

Model Number	SO-1188
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient tripped over the oxygen tubing, was injured.The patient injuries were unknown.The oxygen tubing contributed may have contributed to an injury but did not malfunction.
Event or Problem Description
Patient fell and caught his feet in the tubing. .
Additional Manufacturer Narrative
It was reported that the patient tripped over the oxygen tubing, was injured.The patient injuries were unknown.The oxygen tubing contributed may have contributed to an injury but did not malfunction the complaint investigation was performed based on the content of the issue reported.There were no photo images or videos provided for evaluation; therefore, the complaint is unable to evaluate.No lot number was provided for device history record (dhr) evaluation; therefore, no device history record (dhr) review was conducted.The potential root cause may have been due to excess tubing loosely coiled may have been placed in the way during the patient movement.The ifu for o2 tubing states, 'keep excess tubing loosely coiled out of the way to prevent kinking and tripping hazard.' the complaint history was reviewed in grand avenue from (b)(6) 2022, to (b)(6) 2024, for part number so-1188 for failure mode "tripping", there were one (1) complaint reported for part number so-1188 from (b)(6) 2022, to (b)(6) 2024, timeframe.There is no trend for this product reported.Based on rma-20017c, rev 6, oxygen tubing and accessories, product risk analysis.Under the known and foreseeable hazards "tripping" under id r77.The potential cause(s) of hazard (hazardous situation) for twisted tubing causing fall are 8 = severity, 3 = likelihood of occurrence, rpn = 24; therefore, the risk level is acceptable.Due to the low number of reported complaints and medium/high severity this complaint has a medium risk as stated in risk determination chart: ref-20001-c1 which is aligned to the approved risk management documentation.The regulatory / compliance risk is medium.With the low-level complaints associated with this part number, and the occurrence rate of remote, an hhe should not be considered.We will continue to monitor trends during our periodic complaint review meetings.
Event or Problem Description
Patient fell and caught his feet in the tubing. .

• Brand Name: SALTER LABS
• Common Device Name: PATIENT KIT - (1) #1215, AND (1) #2025 (AIR LIQUIDE
• 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: 18843072
• Report Number: 3000219639-2024-00028
• Device Sequence Number: 8296709
• Product Code: BYX
• UDI-Device Identifier: 00607411889097
• UDI-Public: 00607411889097
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: Lay User/Patient
• Device Model Number: SO-1188
• Device Catalogue Number: SO-1188
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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