SALTER LABS
Report
- Report Number
- 3000219639-2024-00057
- Event Type
- Malfunction
- Date Received
- June 28, 2024
- Date of Event
- May 30, 2024
- Report Date
- July 2, 2024
- Manufacturer
- SALTER LABS
- Product Code
- CAF
- UDI-DI
- 00607411005046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ALL INFORMATION REASONABLY KNOWN AS OF 29 JUNE 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
ALL INFORMATION REASONABLY KNOWN AS OF 29 JUNE 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. THE COMPLAINT REPORTED "NOT WORKING- PT SAID NOT GETTING MEDICATION." THE COMPLAINT INVESTIGATION WAS PERFORMED BASED ON THE CONTENT OF THE ISSUE REPORTED. BASED ON THE COMPLAINT REPORT NO PATIENT WAS AFFECTED, THE ISSUE WAS NOTED AT HOME. THERE WERE NO PHOTO IMAGES OR VIDEOS OF THE REPORTED ISSUE; THEREFORE, THE COMPLAINT WAS UNABLE TO BE CONFIRMED AND NO ROOT CAUSE WAS IDENTIFIED. THE PRODUCT IS UNDER WARRANTY; THEREFORE, THE CUSTOMER IS REQUESTING A WARRANTY REPLACEMENT. THE WARRANTY REPLACEMENT ORDER NUMBER SENT IS (B)(4). A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE REPORTING TO THE CAPA REVIEW BOARD DUE TO THE OCCURRENCE BEING 1-IMPROBABLE. THIS IS THE THIRD (3) COMPLAINT REPORTED FOR PART NUMBER SO-1408GN. THERE WERE SEVENTEEN (17) ADDITIONAL COMPLAINTS REPORTED FOR PART NUMBER SO-1408GN DURING THE SAME TIMEFRAME FOR OTHER FAILURE MODES. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.
NOT WORKING- PT SAID NOT GETTING MEDICATION.
NOT WORKING- PT SAID NOT GETTING MEDICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2206248 | SALTER LABS | PATIENT KIT- COMPRESSOR + NEBULIZER | CAF | SALTER LABS | SO-1408GN | KSN2206-14485 | 00607411005046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |