MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC LEVEL 1 CONVECTIVE WARMER - 120 VOLT CONFIGURATION; WARMER, THERMAL, INFUSION FLUID

Catalog Number	L1-CW-120V
Medical Device Problem Codes	Temperature Problem (3022); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that there was an intermittent issue when turning off the unit.Everything in internal stopped except display temperature which decreased slowly instead of an immediate stop.There was no patient involvement and no patient harm/adverse event reported.

• Brand Name: LEVEL 1 CONVECTIVE WARMER - 120 VOLT CONFIGURATION
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20250595
• Report Number: 3012307300-2024-09534
• Device Sequence Number: 17983429
• Product Code: LGZ
• UDI-Device Identifier: 15019517121551
• UDI-Public: (01)15019517121551(11)181214
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: L1-CW-120V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown