MAUDE Adverse Event Report: ST PAUL LEVEL 1; HOTLINE LOW FLOW SYSTEM

Model Number HL-390

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

One fluid warmer was returned for evaluation.Visual inspection of the device found the enclosure to be cracked at drain fitting, both covers were cracked, alarm on pcb was damaged and line cord was worn.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 tank was filled with water and powered on, confirming the reported customer complaint.This was a result of a cracked enclosure by drain fitting and the problem source has been determined to be user interface.

Event Description

Information was received that device is cracked in the bottom casing.Incident occurred during testing; no patient involvement.

• Brand Name: LEVEL 1
• Type of Device: HOTLINE LOW FLOW SYSTEM
• 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: 10494154
• MDR Text Key: 205675596
• Report Number: 3012307300-2020-09043
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: 10695085002796
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/04/2020

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: Health Professional
• Device Model Number: HL-390
• Device Catalogue Number: HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2019
• 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