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U.S. Department of Health and Human Services

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

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PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC G80 MODULAR PATIENT MONITOR Back to Search Results
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.
 
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Brand NameG80 MODULAR PATIENT MONITOR
Type of DeviceG80 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 Key13389893
MDR Text Key284959416
Report Number3030677-2022-00544
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K063559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number866080
Device Catalogue Number866080
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/19/2022
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

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