MAUDE Adverse Event Report: VITAL SIGNS ENFLOW IV FLUID/BLOOD WARMER, NO CE MARK; WARMER, THERMAL, INFUSION FLUID

Model Number 980105VSD

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint sample was returned for investigation and complete evaluation including functional testing was performed.The investigation results concluded that this unit was burnt.Improper or excessive high voltage was applied to the warmer, causing extensive burn damage to the area around terminal st2 (which should only have 28.5vdc applied).This was most probably caused by the customer connecting the unit to an incorrect power source.A review of the device history record (dhr) was performed and showed there were no identified issues with the material or manufacturing porcess that would have contributed to this issue.The customer was sent the operating manula for this product with the recommendation to follow the indicated approved power sources for this product.

Event Description

Customer verbally stated "item not heating." it was confirmed that there was no patient impact.

Manufacturer Narrative

(b)(4).

• Brand Name: ENFLOW IV FLUID/BLOOD WARMER, NO CE MARK
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): VITAL SIGNS; 75 north fairway drive; totowa NJ 60061
• Manufacturer (Section G): VITAL SIGNS; 20 campus drive; totowa NJ
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4971424
• MDR Text Key: 24141282
• Report Number: 3010838917-2015-00010
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 980105VSD
• Device Lot Number: 00110838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2016
• 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: Unknown
• Patient Sequence Number: 1