MAUDE Adverse Event Report: CAIRE INC. CAIRE STROLLER; STROLLER 1.2L SF

Model Number STROLLER 1.2L SF

Device Problems Moisture Damage (1405); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 03/30/2016

Event Type  Injury  

Manufacturer Narrative

The unit has been returned to the company for inspection.Non-destructive testing is pending.

Event Description

The company was notified on (b)(6) 2016 of an alleged adverse event that occurred on (b)(6) 2016 in germany.The incident was described to the company as: "customer wanted to refill his unit but the filler neck didn't close properly.While trying to close the leak, he burned his hands and had to go to the doctor.".

Manufacturer Narrative

The unit was returned for examination.No leaks were found and there was no visible damage to internal components.The relief valves and pressure retention test were within specification.Normal evaporation testing could not be completed because the qdv was stuck open during filling.On further inspection it was found that there was a possibility of moisture ingression into the equipment.Components from the qdv showed signs of lime scale deposits when stripped from the equipment.The alleged incident reported by the customer was replicated.It would appear that misuse of the device has been the root cause for the incident reported.

Event Description

The company was notified on (b)(6) 2016 of an alleged adverse event that occurred on (b)(6) 2016 in (b)(6).The incident was described to the company as: "customer wanted to refill his unit but the filler neck didn't close properly.While trying to close the leak, he burned his hands and had to go to the doctor.".

• Brand Name: CAIRE STROLLER
• Type of Device: STROLLER 1.2L SF
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer (Section G): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer Contact: neal maloy ; 2200 airport industrial drive; suite 500; ball ground, GA 30107 ; 7707217712
• MDR Report Key: 5651095
• MDR Text Key: 45055540
• Report Number: 3004972304-2016-00016
• Device Sequence Number: 1
• Product Code: BYJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K800742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: STROLLER 1.2L SF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR