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

Catalog Number 317-09-02

Device Problems Air Leak (1008); Inaccurate Flow Rate (1249); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device displayed an air leak alert and suboptimal flow rate.The nurse reported that the patient was cooling on the device before a ct scan, but the issues occurred after returning from the ct scan.Per troubleshooting, the pads were disconnected, and then, they were reconnected one by one.However, the issue was not resolved.The pads were swapped with a new set and therapy was completed without any further issue.

Manufacturer Narrative

The reported issue (it was reported that the device displayed air leak alert and suboptimal flow rate.The nurse reported that the patient was cooling on device before a ct scan, but the issues occurred after returning from the ct scan.Per troubleshooting, the pads were disconnected and the they were reconnected one by one.However, the issue was not resolved.The pads were swapped with a new set and therapy was completed without any further issue.) for this complaint was unconfirmed.According to the test method, flow rate was found to be acceptable on all the returned pads.The flow rate for this product must be above 2.4 l/min m2.The energy connector for the right chest pad was found damaged however, it did not affect the sample returned in any way, it was found to be a cosmetic defect.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2.3 liters per minute, which is the minimum flow rate for a full pad kit.¿ (b)(4).

Event Description

It was reported that the device displayed an air leak alert and suboptimal flow rate.The nurse reported that the patient was cooling on the device before a ct scan, but the issues occurred after returning from the ct scan.Per troubleshooting, the pads were disconnected, and then, they were reconnected one by one.However, the issue was not resolved.The pads were swapped with a new set and therapy was completed without any further issue.

• Brand Name: ARCTICGEL PADS
• Type of Device: ARCTICSUN GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 7138970
• MDR Text Key: 95961187
• Report Number: 1018233-2017-06449
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 317-09-02
• Device Lot Number: NGBU3474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Date Manufacturer Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1