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

Model Number 866080

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 284959416
• Report Number: 3030677-2022-00544
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838029729
• UDI-Public: 00884838029729
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866080
• Device Catalogue Number: 866080
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1