MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. EQ-5000 EQUATOR HIGH FLOW 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 01/17/2014

Event Type  Injury  

Event Description

User facility reported that the device was in use with pt.The time in use was not provided.According to user facility, after use it was found that the pt exhibited redness and welts at their right shoulder.An ice pack was placed on the area.No permanent adverse effects to pt reported.

Manufacturer Narrative

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

• Brand Name: EQ-5000 EQUATOR HIGH FLOW 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 street; rockland MA 02370
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3650161
• MDR Text Key: 4287303
• Report Number: 2183502-2014-00034
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• 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-5000HF
• 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: 02/13/2014
• Distributor Facility Aware Date: 01/17/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Manufacturer Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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