MAUDE Adverse Event Report: VYAIRE MEDICAL OY CABLE FOR CAM14, FOR CASE , 4.6M / 15FT; CABLE, ELECTRODE

Model Number	CABLE FOR CAM14, FOR CASE , 4.6M / 15FT
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the cable, dcar communication host case 15ft experienced a broken socket on cam module and a broken acquisition cable plug during patient use.The user attending health professional cancelled rest of the test needed by the patient.No harm is associated with the event.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: CABLE FOR CAM14, FOR CASE , 4.6M / 15FT
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; helsinki etela-suomen laani; helsinki, 510 ; FI 510
• Manufacturer (Section G): CARLISLE MEDICAL TECHNOLOGIES (DONGGUAN) CO., LTD; no.2 xinhu industrial park, de; dongguan, 52353 3; CH 523533
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15272399
• Report Number: 3010838917-2022-00011
• Device Sequence Number: 5906209
• Product Code: IKD
• UDI-Device Identifier: 10190752113558
• UDI-Public: (01)10190752113558
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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: CABLE FOR CAM14, FOR CASE , 4.6M / 15FT
• Device Catalogue Number: 2016560-002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 08/22/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown