MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; ARCTIC GEL PADS

Model Number 50000000

Device Problems Inaccurate Flow Rate (1249); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2022

Event Type  malfunction  

Event Description

It was reported that the patient temperature was 35.2c, the target temperature was 37.2c, and water temperature was 29.8c.Nurse was confused as to why the water temperature was so low and patient temperature was not higher.Nurse stated that they had one small universal pad on the patient.Mss had nurse to check the flow rate, and nurse stated that that it was 0.3lpm.Mss advised that if the flow rate was below 0.5lpm then the heater would not heat, and if it was below 0.9lpm the heater would be at reduced capacity.Nurse was going to look for an additional small universal pad as well as stop, empty pad, disconnect, reconnect with proper technique.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient temperature was 35.2c, the target temperature was 37.2c, and water temperature was 29.8c.Nurse was confused as to why the water temperature was so low and patient temperature was not higher.Nurse stated that they had one small universal pad on the patient.Mss had nurse to check the flow rate, and nurse stated that that it was 0.3lpm.Mss advised that if the flow rate was below 0.5lpm then the heater would not heat, and if it was below 0.9lpm the heater would be at reduced capacity.Nurse was going to look for an additional small universal pad as well as stop, empty pad, disconnect, reconnect with proper technique.

Manufacturer Narrative

Per additional information received, bd has determined that this mdr event is not reportable.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15259051
• MDR Text Key: 303305850
• Report Number: 1018233-2022-06580
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other