MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. EQ-5000 EQUATOR CONVECTIVE WARMER; DWJ - 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 02/27/2014

Event Type  Injury  

Event Description

User facility reported device was in use with pt for 30-45 minutes when a high temperature alarm occurred.Device was stopped and pt's buttocks were observed to be red.Further information was requested; no permanent adverse effects to pt reported.

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.The actual device was returned and is currently under investigation.

• 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: 3736089
• MDR Text Key: 18311402
• Report Number: 2183502-2014-00184
• 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: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• 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-500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/28/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2014
• Distributor Facility Aware Date: 02/27/2014
• Device Age: 6 YR
• Event Location: Hospital
• Date Manufacturer Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2008
• 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
• Patient Outcome(s): Required Intervention