MAUDE Adverse Event Report: CONSIGNED 115V DOMESTIC HOTLINE; WARMER, THERMAL, INFUSION FLUID

Model Number CON-HL-90

Device Problem Complete Loss of Power (4015)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical device did not have power.There were no reported adverse events.

Manufacturer Narrative

One fluid warmer was returned for evaluation.Visual inspection of the device found it to have a broken pole clamp, an outdated front cover, pcb, and power switch as well as a cracked tank cover.A dhr review was performed subsequent to the manufacturing of the device and prior to its release; no problems were identified during this dhr review.Device underwent functional testing by plugging in line cord into outlet, confirming the reported customer complaint.The power switch was disconnected from the pcb, and the problem source has been determined to be unknown.

• Brand Name: CONSIGNED 115V DOMESTIC HOTLINE
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• MDR Report Key: 10368175
• MDR Text Key: 201713043
• Report Number: 3012307300-2020-07835
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CON-HL-90
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1