MAUDE Adverse Event Report: CAIRE INC. HELIOS U46; LIQUID OXYGEN UNIT, STATIONARY

Catalog Number B-701652-00

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  No Answer Provided  

Manufacturer Narrative

The company has requested the caddy be returned for testing and investigation.If the unit is returned for inspection or we gain any additional insight on this incident, a followup report will be submitted.

Event Description

The company was informed on november 23, 2015 of an event that occurred in (b)(6) of 2012.The alleged incident was described as follows: "evidently in (b)(6) 2012 the patient's mother alleged that the equipment malfunctioned and resulted in a hospitalization." it is unknown the exact date of the incident.Additionally, the details of the incident are unknown.The company is attempting to learn more information about this incident and will submit a follow up report upon receipt of this information.

• Brand Name: HELIOS U46
• Type of Device: LIQUID OXYGEN UNIT, STATIONARY
• Manufacturer (Section D): CAIRE INC.; 2000 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer (Section G): CAIRE INC.; 2000 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer Contact: neal maloy ; 2000 airport industrial drive; suite 500; ball ground, GA 30107 ; 7707217712
• MDR Report Key: 5318472
• MDR Text Key: 34562743
• Report Number: 3004822415-2015-00029
• Device Sequence Number: 1
• Product Code: BYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: B-701652-00
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other