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

Model Number EQ-5000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 11/19/2014

Event Type  Injury  

Event Description

User facility reported the warming device was in use with a patient for an unknown amount of time when the temperature control increased from 46 degrees celsius to 70 degrees celsius.The increased temperature reportedly produced burns on the patient's chest.No information on patient treatment is available.No permanent adverse effects to patient were reported.

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results.

• Brand Name: EQ-5000 EQUATOR CONVECTIVE WARMER
• Type of Device: DWJ - 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: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4345001
• MDR Text Key: 5216472
• Report Number: 2183502-2014-00963
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K011907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQ-5000
• Device Catalogue Number: EQ-5000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2014
• Distributor Facility Aware Date: 11/19/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2010
• 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