MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX600 PATIENT MONITOR

Model Number	865242
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the blood oxygen parameters can't alarm normally.The device was not in use on a patient at the time of event, there was no patient involvement.
Event or Problem Description
The customer reported that the blood oxygen parameters can't alarm normally.The device was not in use on a patient at the time of event, there was no patient involvement.
Additional Manufacturer Narrative
Multiple good faith efforts were made to obtain additional information; however, they were unsuccessful.H3 other text : no response from customer.

• Brand Name: INTELLIVUE MX600 PATIENT MONITOR
• Common Device Name: INTELLIVUE MX600 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12712697
• Report Number: 9610816-2021-10457
• Device Sequence Number: 4774638
• Product Code: DSI
• UDI-Device Identifier: 00884838029095
• UDI-Public: 00884838029095
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 865242
• Device Catalogue Number: 865242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2016
• 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