MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC G70 MODULAR PATIENT MONITOR

Model Number	866079
Medical Device Problem Code	Inappropriate Audible Prompt/Feedback (2280)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there was an alarm fault.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
The device was evaluated by the customer, it was confirmed that the reported issue; 'the monitor does not have normal ecg sound".Only after pressing the alarm pause button.The customer refused to repair the device and no additional information was provided for further investigation.The device remains at customer site.No subsequent calls have been logged for this device/issue.No corrective action is warranted at this time.The available information from this report does not support that this failure represents a systemic, design, or labeling problem.Device evaluation by the customer.

• Brand Name: G70 MODULAR PATIENT MONITOR
• Common Device Name: G70 MODULAR PATIENT MONITOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14977219
• Report Number: 1218950-2022-00575
• Device Sequence Number: 5145375
• Product Code: MWI
• UDI-Device Identifier: 00884838029736
• UDI-Public: 00884838029736
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090785
• 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
• Device Model Number: 866079
• Device Catalogue Number: 866079
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2022
• Initial Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2015
• 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