STROLLER

Additional Manufacturer Narrative

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. SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK PER RULE 21 CFR 801.30(1). THE DEVICE WAS MANUFACTURED AND LABELED IN 2013. TOP FILL STROLLER UNIT (B)(6) WAS EVALUATED ACCORDING TO A PEER-REVIEWED ENGINEERING PROTOCOL. THE UNIT PASSED EACH OF THE FOLLOWING TEST SECTIONS WITHIN THE ACCEPTABLE CRITERIA AND RANGE OF RESULTS PER PROTOCOL: PRESSURE LEAK TEST, PRIMARY RELIEF VALVE (PRV) FUNCTION TEST, SECONDARY RELIEF VALVE (SRV) FUNCTION TEST, PRESSURE RETENTION TEST, PRESSURIZED NORMAL EVAPORATION RATE (PNER) TEST, OPERATING PRESSURE TEST, FLOW RATE TEST, AND QUICK DISCONNECT (QDV) FUNCTION TEST. TESTING ALSO INCLUDED AN EVENT REPLICATION TEST IN WHICH THE UNIT WAS TESTED AT THE HIGHEST SETTING IN THE CORRECT UPRIGHT ORIENTATION IN CONDITIONS EQUIVALENT TO THE EVENT IN AN ATTEMPT TO REPLICATE THE EVENT. THE UNIT SHOWED TYPICAL SIGNS OF FROSTING IN THE CASE WHEN USED AT THE HIGHEST SETTING FOR AN EXTENDED TIME, BUT OXYGEN CONTINUED TO FLOW UNINTERRUPTED FROM THE UNIT. FOLLOW-UP INFORMATION PROVIDED BY DISTRIBUTOR LINDE GMBH INDICATED THAT THEY PERFORMED INTERNAL INVESTIGATION BEFORE FORWARDING THE DEVICE TO CAIRE, WITH THE FOLLOWING RESULTS: RESULT OF THE INVESTIGATION REPORT DATED 4TH OF NOVEMBER 2024: THE SITUATION WAS RECREATED SEVERAL TIMES WITH LIQUID OXYGEN AND THE AFFECTED DEVICE. NO ERROR OCCURRED. THE DEVICE OPERATED WITHIN PARAMETERS SPECIFIED BY THE MANUFACTURER. THE DEVICE COULD BE REUSED. ALL SAFETY-RELEVANT PARTS AND FUNCTIONS WERE CHECKED: PRV: OK. SRV: OK. LEAK TEST: OK. CAIRE'S ENGINEERING EVALUATION DID NOT REPLICATE THE EVENT AND MATCHED RESULTS OBTAINED BY THE DISTRIBUTOR'S INTERNAL INVESTIGATION. NO ROOT CAUSE OF THE ALLEGED EVENT COULD BE DETERMINED. THE DEVICE IS FULLY FUNCTIONAL. THE OTHER CONCERN EXPRESSED BY THE USER IS SERVICE ORIENTED. SERVICE HAS BEEN GIVEN BY OUR TRAINED DISTRIBUTOR. IT APPEARS THE USER IS CONCERNED HYPOTHETICALLY REGARDING SERVICE LOGISTICS WHICH WE CANNOT COMMENT ON. HOWEVER, THE USER FOLLOWED IFU AND DID HAVE TWO DEVICES READY TO AVOID THOSE SERVICE LOGISTICAL PROBLEMS. STROLLER PORTABLE LIQUID OXYGEN RISK ASSESSMENT PLOX-RA-002 REV M WAS REVIEWED AND DETERMINED TO BE ADEQUATE WITHOUT REVISION.

Additional Manufacturer Narrative

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. A FINAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION IF THE UNIT BECOMES AVAILABLE FOR EVALUATION. SECTION D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDIS) # IS INTENTIONALLY BLANK PER RULE 21 CFR 801.30(1). THE DEVICE WAS MANUFACTURED AND LABELED IN 2013.

Description of Event or Problem

AS ORIGINALLY REPORTED BY THE END USER TO GERMANY BFARM: FAILURE OF THE MOBILE LIQUID OXYGEN TANK. OUR DAUGHTER WAS NOT SUPPLIED WITH OXYGEN FOR ABOUT 1 HOUR. THE TANK SHOWS HEAVY SIGNS OF ICING ON THE INSIDE. WE USED THE TANK ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. NEVERTHELESS, LINDE HAS HAD TO REPLACE THE OXYGEN TANK TWICE WITHIN SIX MONTHS DUE TO OTHER PROBLEMS. BUT TODAY'S EVENT COULD HAVE HAD SERIOUS CONSEQUENCES FOR THE PATIENT.