STROLLER
Report
- Report Number
- 3004972304-2023-00014
- Event Type
- Malfunction
- Date Received
- October 25, 2023
- Date of Event
- September 22, 2023
- Report Date
- July 23, 2024
- Manufacturer
- CAIRE INC.
- Product Code
- BYJ
- PMA / PMN Number
- K800742
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 003
Narratives
PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN. THE STROLLER UNIT DID NOT UNDERGO ENGINEERING EVALUATION. THE DESCRIPTION AS REPORTED BY THE END USER (OXYGEN RELEASE IN A SPRAY-LIKE MANNER), IS CONSISTENT WITH IMPROPER CLEANING OF THE QUICK DISCONNECT VALVE. THE END USER'S REPORTED FROSTBITE INJURY AS A RESULT OF CLEANING LIQUID OXYGEN WITH A TISSUE IS ALSO REPRESENTATIVE OF IMPROPER CLEANING AND IMPROPER USE OF THE DEVICE. BASED ON AVAILABLE EVIDENCE, THIS IS A CASE OF USER ERROR. RISK ASSESSMENT PLOX-RA-002 WAS REVIEWED AND WAS DETERMINED ADEQUATE WITHOUT REVISION. USABILITY ASSESSMENT USERIN-7 ADDRESSED THE RISKS ASSOCIATED WITH NOT CLEANING, OR IMPROPERLY CLEANING, THE QUICK DISCONNECT VALVE, LEADING TO POTENTIAL LEAKING AND LIQUID OXYGEN BURN. INSTRUCTIONS FOR PROPER CLEANING ARE INCLUDED IN USER MANUAL MN236. PROPER CLEANING OF THE UNIT IS ALSO ADDRESSED IN USABILITY ASSESSMENT MAIN-1, DAMAGE TO THE UNIT OR COMPONENTS DUE TO IMPROPER CLEANING METHODS. THIS IS ALSO ADDRESSED IN USER MANUAL MN236. ADDITIONAL WARNINGS IN MANUAL MN236 NOTE TO CALL THE HEALTHCARE PROVIDER IN THE EVENT OF LIQUID OXYGEN LEAK, AND NOT ATTEMPT TO STOP THE LIQUID OXYGEN FROM ESCAPING.
PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN. UDI RELATED DATA QUALITY UPDATES ONLY. SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK PER RULE 21 CFR 801.30(8). THE DEVICE WAS INTENDED FOR EXPORT ONLY.
PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN. CAIRE CUSTOMER SERVICE HAS REQUESTED THE UNIT BE RETURNED TO CAIRE'S LANGENFELD, GERMANY FACILITY FOR EVALUATION, TO RULE OUT USER ERROR RELATED TO VALVE CLEANING. A FINAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION IF THE UNIT BECOMES AVAILABLE FOR EVALUATION.
AS REPORTED TO CAIRE: THE CUSTOMER REPORTED THAT THE PORTABLE DEVICE HAS NOT BEEN FUNCTIONING AS EXPECTED AND THAT IT HAD BEEN RELEASING OXYGEN IN SPRAY-LIKE MANNER. IN THE PREVIOUS WEEK ((B)(6)), CUSTOMER HAD FILLED THE PORTABLE DEVICE. AFTER THIS FILLING, THE DEVICE STARTED TO SPRAY OXYGEN IN THE SAME MANNER AS BEFORE FROM THE CONNECTION HOSE. [CAIRE FOLLOWED UP WITH THE REPORTER AND DETERMINED THAT "CONNECTION HOSE" REFERS TO THE SIDE FILL CONNECTOR ON THE PORTABLE DEVICE.] CUSTOMER TRIED TO CLEAN/STOP THE SPRAYING WITH A TISSUE. THIS CAUSED CUSTOMER A FROSTBITE (1-2.5CM BLISTER TO INDEX FINGER) WHICH CAUSED PAIN. AT THE REPORTING TIME THE CUSTOMER STATED THAT THE FINGER WAS STILL ACHING. CUSTOMER HAS NOT SHOWN THE FROSTBITE TO A HEALTHCARE PROFESSIONAL AND HAS NO INTENTION TO DO SO AT THE TIME OF REPORTING. ACCORDING TO CUSTOMER, THERE ARE NO PROBLEMS USING THE DEVICE IN GENERAL. THE DESCRIPTION REPRESENTS THE BEST INFORMATION AVAILABLE TO CAIRE AT THE TIME OF REPORTING. CAIRE CUSTOMER SERVICE ATTEMPTED WITHOUT SUCCESS TO OBTAIN ADDITIONAL INFORMATION ON THE CONDITIONS PRESENT AT THE TIME OF THE INCIDENT. CAIRE DETERMINED CONSERVATIVELY THAT THIS INCIDENT IS REPORTABLE, DESPITE LACK OF BETTER INFORMATION AT TIME OF REPORTING BECAUSE USER RECEIVED FROSTBITE INJURY (1-2.5CM BLISTER TO INDEX FINGER). CAIRE CUSTOMER SERVICE HAS REQUESTED THE UNIT BE RETURNED TO CAIRE'S LANGENFELD, GERMANY FACILITY FOR EVALUATION, TO RULE OUT USER ERROR RELATED TO VALVE CLEANING. A FINAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION IF THE UNIT BECOMES AVAILABLE FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1047608 | STROLLER | UNIT, LIQUID OXYGEN, PORTABLE | BYJ | CAIRE INC. | 10845200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |