MAUDE Adverse Event Report: ST PAUL LEVEL 1; WARMER, THERMAL, INFUSION FLUID

Device Problem Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: one level 1 hotline low flow systems - hl-90 was returned for analysis.The device had wear and tear damage to the drain fitting, tank cover, front cover, and line cord.The printed circuit board was outdated.The analysis started with a visual inspection then filled the tank with water, attached temp check, plugged in line cord, and turned on power switch.The reported issue was confirmed.The device wouldn't turn on because the power switch was damaged where it connects to the printed circuit board.The cause is a wear and tear issue attributed to the customer.The drain fitting, tank cover, front cover, line cord, membrane switch, and reflux plug were replaced.Also the printed circuit board was upgraded.

Event Description

Information was received indicating that the level 1 hotline low flow systems - hl-90 won't turn on.There were no adverse events reported.

• Brand Name: LEVEL 1
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10064284
• MDR Text Key: 191241250
• Report Number: 3012307300-2020-04490
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 05/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2003
• 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