MAUDE Adverse Event Report: ST PAUL HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported the device was being tested and the device alarm did not sound when alarm was expected.No patient involvement.

Manufacturer Narrative

Other, other text: , corrected data: this event report was determined a duplicate of existing file mdr 3012307300-2020-10631.

Event Description

This event report was determined a duplicate of existing file mdr 3012307300-2020-10631.

• Brand Name: HOTLINE FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10752241
• MDR Text Key: 213613007
• Report Number: 3012307300-2020-10744
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1