MAUDE Adverse Event Report: SMITH¿S MEDICAL ASD, INC. LEVEL 1 BLOWER EQ-5000 230V UK EQUATOR; SYSTEM, THERMAL REGULATING

Model Number	EQ-5000
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.Investigation summary: the affected device was returned for evaluation.Visual inspection performed.Device looks to be in used condition.Small scratches on housing visible.No hose clip provided.Membrane switch was faulty.Warming hose and power cord were provided.Functional testing performed.The customer's problem was duplicated.The root cause was the thermistor or thermistor cable, which was defective.No warming function.Faulty hose was replaced.Electrical safety and functional test passed after repair.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
It was reported that while testing the temperature of the warmer, incorrect readings were received.In one instance, when setting the temperature to 36 degrees celsius, the device showed a recording of 12 degrees celsius.There was unknown patient involvement reported.

• Brand Name: LEVEL 1 BLOWER EQ-5000 230V UK EQUATOR
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITH¿S MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20609855
• Report Number: 3012307300-2024-12678
• Device Sequence Number: 18124874
• Product Code: DWJ
• UDI-Device Identifier: 50695085850005
• UDI-Public: (01)50695085850005(11)110118
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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 Model Number: EQ-5000
• Device Catalogue Number: EQ-5000-UK-230V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2011
• 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