MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM ASSY, CABLE, TEMP OUT, PHONO PLUG; ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM ASSY, CABLE

Model Number	73555
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the customer originally ordered a quantity of 2 with product number 735-55, temperature out phono plug ge.Stated that the order received through partssource, the box contained 2 bags both identified as 735-55 however they contained 2 different parts.One was the ge phono jack 735-55 what was depicted in the attachment.The other was a 735-56, philips connector in which the bag marked 755-55.The user just received the replacement part and it had the same issue, received a bag marked 735-55 with the philips connector, 735-56.
Event or Problem Description
It was reported that the customer originally ordered a quantity of 2 with product number 735-55, temperature out phono plug ge.Stated that the order received through partssource, the box contained 2 bags both identified as 735-55 however they contained 2 different parts.One was the ge phono jack 735-55 what was depicted in the attachment.The other was a 735-56, philips connector in which the bag marked 755-55.The user just received the replacement part and it had the same issue, received a bag marked 735-55 with the philips connector, 735-56.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was initially reported in error as this 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.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM ASSY, CABLE, TEMP OUT, PHONO PLUG
• Common Device Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM ASSY, CABLE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 11517005
• Report Number: 1018233-2021-01408
• Device Sequence Number: 11743725
• Product Code: DWJ
• UDI-Device Identifier: 00801741080371
• UDI-Public: (01)00801741080371
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K161602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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
• Device Model Number: 73555
• Device Catalogue Number: 73555
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other