MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1; SYSTEM, THERMAL REGULATING

Model Number L1-CW-220V

Device Problems Device Alarm System (1012); Pumping Stopped (1503)

Patient Problem Hypothermia (1915)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Foreign: (b)(6).

Event Description

Information was received indicating that a smiths medical heater automatically switched off when in used.The occlusion and service indication alarms went off.They reset the device per the manual but still the alarms remained.The device stopped warming and kept alarming.The patient got hypothermia as a result.No other adverse events reported.

Event Description

A technical support engineer with the company organized a meeting with the customer on (b)(6) 2020 in an attempt to trouble shoot the reported product problem.The support engineer noted that the occlusion/maintenance alarm was activated when the hose was disconnected from the unit.This was also reported by the customer.The support engineer noted further that this was an expected outcome that is outlined in the instructions for use (ifu) for the device.In addition to the above, the support engineer also discovered a secondary problem that was not reported by the customer.When the device was operated in the ambient state (i.E.When the unit blows ambient air into the blanket) an occlusion alarm was produced.This was a fault that should not have occurred.The evaluation of the affected device at the investigation site is still pending.A supplemental report will be sent after the device evaluation is completed.

Manufacturer Narrative

Returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to user interface.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: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; prime tower, business bay, p o; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 11008908
• MDR Text Key: 221452278
• Report Number: 3012307300-2020-19950
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: AE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: L1-CW-220V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2019
• 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
• Patient Outcome(s): Other