MAUDE Adverse Event Report: NULL LEVEL 1 HOTLINE LOW FLOW SYSTEM; WARMER, THERMAL, INFUSION FLUID

Catalog Number CON-HL-90

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Other text: one smiths medical level 1 hotline low flow system was returned for analysis with a cracked tank cover, outdated printed circuit board (pcb) and power switch.In addition, wear and tear damaged enclosure was noted with blood on the line cord.During analysis the reported issue was duplicated, the returned device could not be calibrated due to damaged pot on pcb.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be faulty pcb.

Event Description

Information was received indicating that during testing, a smiths medical level 1 hotline low flow system had a bad port on printed circuit board (pcb).No patient was involved in this event.No adverse effects were reported.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEM
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section G): NULL
• MDR Report Key: 10171216
• MDR Text Key: 195655363
• Report Number: 3012307300-2020-06064
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1