MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. EQ-5000 EQUATOR CONVECTIVE WARMER

Model Number EQ-5000

Device Problems Charred (1086); Electrical Overstress (2924)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

User facility reported that the power cord burned and damaged the attached convective warmer.No adverse effects to patient or users reported.Power cord has been discarded; return of convective warmer has been requested.

Manufacturer Narrative

Manufacturer completed the entire form.Some medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Manufacturer Narrative

The used warming device was returned without it's main cable or hose.Visual inspection observed smoke residue on the warming device where the main cord plugs into the device.During functional testing, a new power cord and hose were attached to the warming device.The device performed self-test with no issues observed.The device was set to each of its three temperature setting; all temperatures found within specification.Electrical testing found no electrical surges or performance issues.The main socket, hose, and main cord were replaced.Inspection and testing of the device could not determine a root cause for the smoke residue found at the main cord socket.

• Brand Name: EQ-5000 EQUATOR CONVECTIVE WARMER
• Type of Device: CONVECTIVE WARMER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; rockland MA
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.,; 160 weymouth st.; rockland MA 02370
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4902370
• MDR Text Key: 6018034
• Report Number: 2183502-2015-00466
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K011907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQ-5000
• Device Catalogue Number: EQ-5000-FR-230V
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2015
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2011
• 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