MAUDE Adverse Event Report: CAREFUSION, INC WARMER, REUSABLE, ENFLOW

Catalog Number 980105VS

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported issue was confirmed in the laboratory setting.The root cause of the reported issue was the device being connected to an incorrect power source (incorrect voltage).Carefusion provided the customer with the system manual for this product providing the correct product specifications.(b)(4).

Event Description

The customer reported the enflow warmer looks like it had a "boom" on the inside which caused a dimple on the outside.The customer clarified that the part where the label is located on the back of the warmer is dimpled out.

• Brand Name: WARMER, REUSABLE, ENFLOW
• Type of Device: WARMER, REUSABLE, ENFLOW
• Manufacturer (Section D): CAREFUSION, INC; 17400 medina road suite 100; minneapolis MN 55447
• Manufacturer (Section G): HEALTHCARE TECHNOLOGY INTL LTD; yin yang industrial estate, zh; dongguan; guangdong 53262 0; CH 532620
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5958808
• MDR Text Key: 55332957
• Report Number: 2031702-2016-00930
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 980105VS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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