MAUDE Adverse Event Report: PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC G80 MODULAR PATIENT MONITOR

Model Number	866080
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer replaced the cable and no relevant information was provided for further investigation.The cause of the burned cable was unknown, therefore this will be considered a product malfunction.The device returned to full functionality.The device remains at the customer site, no further evaluation is required at this time, no subsequent calls have been logged for this device/issue.
Event or Problem Description
It was reported that when using the device to monitor the patient's physical signs, the device suddenly went black and began smoking from the rear hatch.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: G80 MODULAR PATIENT MONITOR
• Common Device Name: G80 MODULAR PATIENT MONITOR
• Manufacturer (Section D): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• Manufacturer (Section G): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13389893
• Report Number: 3030677-2022-00544
• Device Sequence Number: 4675552
• Product Code: LNH
• UDI-Device Identifier: 00884838029729
• UDI-Public: 00884838029729
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063559
• 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
• Type of Report: Initial

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: 866080
• Device Catalogue Number: 866080
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 01/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown