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

Model Number SO-1188

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/06/2024

Event Type  Injury  

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 Description

Patient fell and caught his feet in the tubing. .

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 Description

Patient fell and caught his feet in the tubing. .

• Brand Name: SALTER LABS
• Type of Device: 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
• MDR Text Key: 336959420
• Report Number: 3000219639-2024-00028
• Device Sequence Number: 1
• Product Code: BYX
• UDI-Device Identifier: 00607411889097
• UDI-Public: 00607411889097
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/06/2024
• 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