MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. EQUATOR CONVECTIVE WARMER; SYSTEM, THERMAL REGULATING

Catalog Number	EQ-5000JP
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the disconnect indicator alarm sounds.There was known patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.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 reportable information becomes available.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: one device was received.No abnormality related to the reported event was confirmed on the product's appearance.During the functional testing, when the power is turned on, the disconnect indicator alarm sounds.The cause of the problem was found to be the disconnection of the sensor cable in hose.The hose was replaced.A device history record serial number.

• Brand Name: EQUATOR CONVECTIVE WARMER
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20494599
• Report Number: 3012307300-2024-11532
• Device Sequence Number: 17020903
• Product Code: DWJ
• UDI-Device Identifier: 50695085850005
• UDI-Public: (01)50695085850005(11)100908
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: EQ-5000JP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 10/26/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2010
• 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