MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS¿ CABLE FOR CAM14 FOR MAC5500¿, 1.3M / 4.2FT; CABLE, ELECTRODE

Model Number	VITAL SIGNS¿ CABLE FOR CAM14 FOR MAC5500¿, 1.3M / 4.2FT
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).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.
Event or Problem Description
The customer reported that the vital signs¿ cable for cam14 for mac5500¿, 1.3m / 4.2ft locking pin is snapped.Due to this, it burned the power supply assembly mac 5000 - rohs and damaged the power supply cord ra control europe 10a 250v 2.5m.They also noticed the cracked writer base mac series and weak gas shock absorber cylinder.All of the damaged equipment have been replaced, tested for operation and leakage current.There is no patient involvement.

• Brand Name: VITAL SIGNS¿ CABLE FOR CAM14 FOR MAC5500¿, 1.3M / 4.2FT
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): CARLISLE MEDICAL TECHNOLOGIES (DONGGUAN) CO., LTD; no.2 xinhu industrial park,; dengwu village, qiaotou town; dongguan, 52353 3; CH 523533
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, CA 92618
• MDR Report Key: 14795141
• Report Number: 3013596024-2022-00005
• Device Sequence Number: 14716922
• Product Code: IKD
• UDI-Device Identifier: 10190752113541
• UDI-Public: (01)10190752113541
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2022

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: VITAL SIGNS¿ CABLE FOR CAM14 FOR MAC5500¿, 1.3M / 4.2FT
• Device Catalogue Number: 2016560-001
• Device Lot Number: NOT PROVIDED
• 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: 06/07/2022
• Initial Report FDA Received Date: 06/23/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown