SALTER LABS
Report
- Report Number
- 3000219639-2022-00023
- Event Type
- Injury
- Date Received
- May 4, 2022
- Date of Event
- February 4, 2022
- Report Date
- May 3, 2022
- Manufacturer
- SALTER LABS
- Product Code
- CAT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
IT WAS REPORTED THAT THE PATIENT TRIPPED OVER THE OXYGEN TUBING AND PATIENT WAS INJURED, REQUIRING SURGERY. THE PATIENT IS NOW IN A SLING FROM SURGERY. THE OXYGEN TUBING CONTRIBUTED MAY HAVE CONTRIBUTED TO AN INJURY BUT DID NOT MALFUNCTION.
IT WAS REPORTED THAT THE PATIENT TRIPPED OVER THE OXYGEN TUBING AND PATIENT WAS INJURED, REQUIRING SURGERY. THE PATIENT IS NOW IN A SLING FROM SURGERY. THE OXYGEN TUBING CONTRIBUTED MAY HAVE CONTRIBUTED TO AN INJURY BUT DID NOT MALFUNCTION COMPLAINT HISTORY REVIEWED. THERE HAVE BEEN TWO SIMILAR COMPLAINTS IN THE PREVIOUS 24 MONTHS FOR THIS ISSUE. LONGER TUBING ALLOWS FOR GREATER PATIENT MOBILITY DURING HOME USE, BUT INCREASES INHERENT RISK OF TRIPPING DUE TO TUBING LAYING ON THE FLOOR, AND CAN BE MITIGATED WITH A SWIVEL CONNECTOR (1225-0) SEE REF-10021 - TRIPPING COMPLAINTS REFERENCE FOR FURTHER INFORMATION. RISK(RMA- (B)(6) ): R86: SEVERE INJURY FROM FALL - TUBING CAUGHT ON OBJECTS OR PATIENT'S FEET - S=8, O=2, RPN=16. RPN < 25 THEREFORE RISK IS ACCEPTABLE.
PATIENT TRIPPED ON OXYGEN TUBING CAUSING INJURY. PATIENT REQUIRED SURGERY AND HAD LEFT ARM IN SLING AFTER SURGERY.
PATIENT TRIPPED ON OXYGEN TUBING CAUSING INJURY. PATIENT REQUIRED SURGERY AND HAD LEFT ARM IN SLING AFTER SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2244041 | SALTER LABS | PATIENT KIT- OXYGEN- SEE ORACLE FOR FULL DESCRIPTION | CAT | SALTER LABS | SO-1844 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |