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

Model Number EQ-5000

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Burn(s) (1757)

Event Date 02/19/2014

Event Type  Injury  

Event Description

User facility reported device was in use with the patient at 44c temperature setting with a warming blanket folded over at the top of the patient's body.After 30 minutes in use, device alarmed for high temperature.User stopped device and restarted 10 minutes later at 40c temperature setting.Following procedure, patient was checked and found to have burns on their chest.User facility treated burns with cold water and biafine.

Manufacturer Narrative

The device is currently being evaluated; the mfr will file a follow up report detailing the results of the evaluation once it is completed.Method - the actual device was returned and is currently under investigation.

• Brand Name: EQ-5000 EQUATOR 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: 3716150
• MDR Text Key: 4332842
• Report Number: 2183502-2014-00142
• 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
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2014
• 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?: Yes
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2014
• Distributor Facility Aware Date: 02/19/2014
• Device Age: 5 YR
• Event Location: Hospital
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2009
• 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
• Patient Outcome(s): Required Intervention