Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS SALTER LABS; PATIENT KIT - (1) #1215, AND (1) #2025 (AIR LIQUIDE)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SALTER LABS SALTER LABS; PATIENT KIT - (1) #1215, AND (1) #2025 (AIR LIQUIDE) Back to Search Results
Model Number SO-1188
Device Problem Material Twisted/Bent (2981)
Patient Problem Bruise/Contusion (1754)
Event Date 11/23/2023
Event Type  Injury  
Event Description
The patient caught her feet in the tube and fell: large bruises on the right thigh + a cracked rib, her condition did not require hospitalization.
 
Manufacturer Narrative
It was reported that the patient tripped over the oxygen tubing, was injured.The patient received cracked ribs, large ribs, but did not need to be hospitalized.The oxygen tubing contributed may have contributed to an injury but did not malfunction.
 
Manufacturer Narrative
It was reported that the patient tripped over the oxygen tubing, was injured.The patient received cracked ribs, large ribs, but did not need to be hospitalized.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.The potential root cause may have been due to excess tubing loosely coiled may have been placed in the way during the patient movement.Based on rma-020017c rev 6, id rc30: ifu for o2 tubing states, 'keep excess tubing loosely coiled out of the way to prevent kinking and tripping hazard.' no lot number was provided for device history record (dhr) evaluation; therefore, no device history record (dhr) review was conducted.The complaint history was reviewed in grand avenue from january 31, 2022, to january 31, 2024, for part number so-1188 for failure mode "tripping", there were one (1) complaint reported for part number so-1188 from january 31, 2022, to january 31, 2024, timeframe.There is no trend for this product report.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
The patient caught her feet in the tube and fell: large bruises on the right thigh + a cracked rib, her condition did not require hospitalization.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18822985
MDR Text Key336733373
Report Number3000219639-2024-00013
Device Sequence Number1
Product Code BYX
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
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 03/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberSO-1188
Device Catalogue NumberSO-1188
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2024
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 Number1
Patient Outcome(s) Other;
-
-