MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® LEVEL 1® H-1025 FAST FLOW FLUID WARMER; SYSTEM, THERMAL REGULATING

Model Number H-1000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that this fast flow fluid warmer exhibited a burning smell while in use.No adverse patient effects were reported.

Manufacturer Narrative

One level 1® level 1® h-1025 fast flow fluid warmer was received in used condition.The customer's reported problem could not be confirmed.When the unit was turned on, no unusual smell was detected.The technician opened the device and inspected all parts (especially both heaters).No burn marks or other failures were found.The unit passed all functional tests.

• Brand Name: LEVEL 1® LEVEL 1® H-1025 FAST FLOW FLUID WARMER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7327723
• MDR Text Key: 102019449
• Report Number: 3012307300-2018-00550
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: H-1000
• Device Catalogue Number: H-1000-GE-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1