MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX450 PATIENT MONITOR

Model Number 866062

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

Philips received information stating that on (b)(6) 2024, the ward round found that the blood oxygen saturation of a patient was 94%, the ward immediately checked the oxygen absorption of the patient, and assessed the patient's consciousness, breathing sound, sputum sound, and hypoxia.It was found that the patient had no hypoxia, and the pulse oxygen clip was disconnected, but the blood oxygen saturation still showed a value.The device was in clinical use.There was no adverse event or patient harm reported.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.E1: reporting institution phone #: (b)(6).E1: reporter phone #: (b)(6).

Manufacturer Narrative

A philips engineer confirmed the reported problem and found out that the blood oxygen probe was defective.The hospital equipment department replaced the blood oxygen probe and the equipment returned to normal use.A gfe was performed to get the additional information regarding spo2 clip manufacturer and other information related to patient diagnosis, but it was unknown.The customer ordered a replacement blood oxygen probe to resolve the issue.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MX450 PATIENT MONITOR
• Type of Device: INTELLIVUE MX450 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 18855823
• MDR Text Key: 337511545
• Report Number: 9610816-2024-00131
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038769
• UDI-Public: 00884838038769
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• 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
• Device Operator: Health Professional
• Device Model Number: 866062
• Device Catalogue Number: 866062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2020
• 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