MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER

Model Number 862442

Device Problem High Readings (2459)

Patient Problems Hypoxia (1918); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2023

Event Type  malfunction  

Event Description

The customer reported that the intellivue multi measurement server provided spo2 readings that were inaccurately high for a ventilated patient.The device was in use monitoring a patient at the time of the reported issue.No death or patient / user injury or harm was reported.

Manufacturer Narrative

Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that the intellivue multi measurement server provided spo2 readings that were inaccurately high for a ventilated patient, resulting in the patient becoming hypoxic.The device was in use monitoring a patient at the time of the reported issue.A serious injury was reported.

Manufacturer Narrative

At the time of the event, the customer reported the spo2 cables were connected to an mp70 along with the spo2 sensor on the patient's finger.It was unknown if the waveform and signal quality appeared to be good, when spo2 was gave a false high reading.The biomed (bmed) tested the unit onsite and could not confirm the customer's allegations.The unit functioned as intended along with the spo2 sensor and spo2 cables.The device worked to specification with no errors.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER
• Type of Device: INTELLIVUE MULTI MEASUREMENT SERVER
• 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: 16767718
• MDR Text Key: 313560841
• Report Number: 9610816-2023-00173
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838000254
• UDI-Public: 00884838000254
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862442
• Device Catalogue Number: 862442
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 04/11/2023; 04/27/2023
• Supplement Dates FDA Received: 04/20/2023; 05/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2014
• 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
• Patient Outcome(s): Other