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

Catalog Number UNKNOWN

Device Problem Disconnection (1171)

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

Event Date 10/18/2022

Event Type  malfunction  

Event Description

It was reported that nurse stated they were turning the patient and one of the pads came loose from the fluid delivery line, and water went everywhere.Now nurse had bubbles in the line and device would not start.Mss had nurse stop therapy, empty pads, disconnect pads, reconnect pads with proper technique, and resume therapy.Device alarmed alarm 4 (water reservoir below minimum).Mss walked nurse through how to add water to the reservoir, but nurse could not do this while mss were on the phone.Nurse stated they had to get the sterile water from downstairs and would call back with any additional issues.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿ inadequate labeling of device for proper connection improper design of pad connector- pad not connected to fluid delivery line pad connector not properly attached to fluid delivery line'¿.The dhr review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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.

Event Description

It was reported that nurse stated they were turning the patient and one of the pads came loose from the fluid delivery line, and water went everywhere.Now nurse had bubbles in the line and device would not start.Mss had nurse stop therapy, empty pads, disconnect pads, reconnect pads with proper technique, and resume therapy.Device alarmed alarm 4 (water reservoir below minimum).Mss walked nurse through how to add water to the reservoir, but nurse could not do this while mss were on the phone.Nurse stated they had to get the sterile water from downstairs and would call back with any additional issues.

• Brand Name: ARCTIC GEL PADS
• Type of Device: UNKNOWN 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15710419
• MDR Text Key: 306735153
• Report Number: 1018233-2022-08281
• Device Sequence Number: 1
• Product Code: DWJ
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• 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