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

Model Number 50000000

Device Problem Gas/Air Leak (2946)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient was not trending to target temperature on the arctic sun device.Therapy started two hours ago and patient temperature was 38.2 c, target temperature was 33 c, water temperature was 5.3 c, flow rate was 1.9, and trend indicator (tdi) was neutral.Patient weight was 112 kg with large pads and no universal.Nurse noted no shivering, seizing or infection in the patient.Ms&s explain how to assess for micro shivering and told to obtain inlet pressure (ip) then to disconnect and reconnect pads.Pads were disconnected right away for ct (computed tomography) and nurse was unable to get inlet pressure (ip).Ms&s explained the patient would need coverage over the abdominal area and reminded nurse to do frequent skin assessments.

Event Description

It was reported that the patient was not trending to target temperature on the arctic sun device.Therapy started two hours ago and patient temperature was 38.2 c, target temperature was 33 c, water temperature was 5.3 c, flow rate was 1.9, and trend indicator (tdi) was neutral.Patient weight was 112 kg with large pads and no universal.Nurse noted no shivering, seizing or infection in the patient.Ms&s explain how to assess for micro shivering and told to obtain inlet pressure (ip) then to disconnect and reconnect pads.Pads were disconnected right away for ct (computed tomography) and nurse was unable to get inlet pressure (ip).Ms&s explained the patient would need coverage over the abdominal area and reminded nurse to do frequent skin assessments.

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 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 the patient was not trending to target temperature on the arctic sun device.Therapy started two hours ago and patient temperature was 38.2 c, target temperature was 33 c, water temperature was 5.3 c, flow rate was 1.9, and trend indicator (tdi) was neutral.Patient weight was 112 kg with large pads and no universal.Nurse noted no shivering, seizing or infection in the patient.Ms&s explain how to assess for micro shivering and told to obtain inlet pressure (ip) then to disconnect and reconnect pads.Pads were disconnected right away for ct (computed tomography) and nurse was unable to get inlet pressure (ip).Ms&s explained the patient would need coverage over the abdominal area and reminded nurse to do frequent skin assessments.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿use of punctured pads or pad lines¿.It is unknown whether the device had met relevant specifications.The product was used for diagnostic and treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the arctic gel pads ifus are found to be adequate based on past reviews.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: UNKNOWN ARCTICGEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 11297804
• MDR Text Key: 230938480
• Report Number: 1018233-2021-00347
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• 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,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other