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

Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they aware of the pad issue in the (b)(6) neonatal intensive care unit (nicu).They came upon two more sets and with the same issue this week on 9se.These pads did not stick either, peeled back on to themselves on several pads and as the water temperatures fluctuated, the gel came off the pads and on to the patient, almost in a melting fashion.They were not sure if there has been a different manufacturer over the last few years and the pads have been getting worse and worse that was material coming off around the hoses and then pads not sticking to the patient, but this was the worst condition they have seen them.They concerned since it was two different units and buildings and most likely two different lots.The picture of the below was peel back from the pads on 9se, but they did not have the lot number of these pads.Other pictures below were the pads from the (b)(6) neonatal intensive care unit (nicu) being held together, and the packaging, lot #nghy5076.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be "improper design consideration or material selection".However, there was insufficient information to confirm this potential root cause.A dhr review is not required as the lot number is unknown.The product catalog number and lot number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - the information provided by bd represents all 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 bd.
Event or Problem Description
It was reported that they aware of the pad issue in the jhn neurosensory intensive care unit (nicu).They came upon two more sets and with the same issue this week on 9se.These pads did not stick either, peeled back on to themselves on several pads and as the water temperatures fluctuated, the gel came off the pads and on to the patient, almost in a melting fashion.They were not sure if there has been a different manufacturer over the last few years and the pads have been getting worse and worse that was material coming off around the hoses and then pads not sticking to the patient, but this was the worst condition they have seen them.They concerned since it was two different units and buildings and most likely two different lots.The picture of the below was peel back from the pads on 9se, but they did not have the lot number of these pads.Other pictures below were the pads from the jhn neurosensory intensive care unit (nicu) being held together, and the packaging, lot #nghy5076.Per follow up information received via email on 10may2024, biomed spoke to arctic sun support and there was no need to send in device.The pads were affected.The pads were removed from patient and new pads delivered by representative.Both patients affected when through two sets of pads and they completed therapy on the same device but different pads.Patient did not adequately cool until the pad problem was detected and the pads were switched out.There are 4 sets of pads were defective.The problem occurred the entire cooling cycle for all pads.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Common Device Name: 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: 19229249
• Report Number: 1018233-2024-02442
• Device Sequence Number: 12478847
• Product Code: DWJ
• UDI-Device Identifier: 00801741080005
• UDI-Public: (01)00801741080005
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown