MAUDE Adverse Event Report: CAIRE INC. STROLLER; LIQUID OXYGEN UNIT, PORTABLE

Model Number STROLLER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/22/2016

Event Type  Injury  

Manufacturer Narrative

The unit has been returned and pending testing.Once testing has been completed, a followup report will be submitted.

Event Description

The company was informed on november 3, 2016 of an adverse event involving a stroller unit.The patient could not receive oxygen from this unit because it was frozen.The patient's oxygen saturation dipped down to 80%.

Manufacturer Narrative

The unit was returned to the company for inspection.All of the device's components were present and undamaged.There were no leaks detected and the device performed to manufacturer's specifications.The alleged incident reported could not be duplicated.

Event Description

The company was informed on (b)(6) 2016 of an adverse event involving a stroller unit.The patient could not receive oxygen from this unit because it was frozen.The patient's oxygen saturation dipped down to 80%.

• Brand Name: STROLLER
• Type of Device: LIQUID OXYGEN UNIT, PORTABLE
• 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: 6141691
• MDR Text Key: 61344371
• Report Number: 3004972304-2016-00039
• Device Sequence Number: 1
• Product Code: BYJ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K800742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: STROLLER
• Device Catalogue Number: 10956680
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other