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

Model Number HL-390

Device Problems Failure to Calibrate (2440); Calibration Problem (2890)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical level 1 hotline low flow system could not be calibrated.No adverse effects were reported.

Manufacturer Narrative

Other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source is unknown.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: LEVEL 1
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• MDR Report Key: 11596045
• MDR Text Key: 243165669
• Report Number: 3012307300-2021-02702
• 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: 05/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• 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: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1