MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® H-1200 FAST FLOW FLUID WARMER 230V UK; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Catalog Number 8002916

Device Problems Device Emits Odor (1425); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2016

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.(b)(4).

Event Description

It was reported that when a level 1 fast fluid warmer was switched on it made a loud "bang noise" and then there was a strong burning smell.The device was not being used on a patient at the time it was switched on.The customer verified that the machine was not smoking.No adverse health outcomes were reported.

Manufacturer Narrative

The reported, used, device was returned for investigation.Visual inspection of the device revealed that heater number two was non-functional.Further inspection of the device found no evidence of water damage or exposed wires.During electrical resistance testing (ohms), it was found that heater number one was within specification; however, heater number two was an open circuit.Investigation was unable to determine the root cause of the non-functional heater.

• Brand Name: LEVEL 1® H-1200 FAST FLOW FLUID WARMER 230V UK
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL OAKDALE; 3350 granada avenue north; suite 100; oakdale MN 55128
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6112564
• MDR Text Key: 60430962
• Report Number: 3012307300-2016-00369
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8002916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2008
• 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