MAUDE Adverse Event Report: SMITH'S MEDICAL ASD, INC. LEVEL 1 CONVECTIVE WARMER; SYSTEM, THERMAL REGULATING

Catalog Number	L1-CW-100VJP
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.The device has not been returned to the manufacturer.
Event or Problem Description
It was stated that the thermistor connection failure was suspected.There was patient involvement and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.Visual inspection performed.No abnormality related to the reported event was confirmed on the product's appearance.Functional testing was performed.The reported event was not reproduced.Only the frequent occurrence of error 20 was confirmed on the operation log.It is presumed from the log history that a poor contact of the thermistor cable occurred.As a precautionary measure, the l1-hose was replaced.L1-cw device passed all functional tests.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: LEVEL 1 CONVECTIVE WARMER
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITH'S MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20685578
• Report Number: 3012307300-2024-13288
• Device Sequence Number: 8557021
• Product Code: DWJ
• UDI-Device Identifier: 15019517121551
• UDI-Public: (01)15019517121551
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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-100VJP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 11/24/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/20/2024
• 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