MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70

Model Number 862451

Device Problem Delayed Alarm (1011)

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

Event Date 12/10/2023

Event Type  malfunction  

Event Description

The customer reported that the monitor did not alarm for spo2 with the alarm limit set at 80 until the patient was at 30.The device was in use on patient at time of event, there was no adverse event reported.The customer simulated spo2 red and yellow alarms and got the visual and audio alarms.A field service engineer (fse) is needed to check the clinical audit trail to verify the alarm that the customer claims was missed.

Manufacturer Narrative

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.

Manufacturer Narrative

Philips received a complaint on the intellivue mp70 indicating that the monitor did not call the oxygen saturation (spo2) alarm for alarm limit set at 80 until patient was at 30.The remote service engineer (rse) spoke to the customer and had the customer simulate spo2 red and yellow alarms, and he got the visual and audio alarms.The rse planned to dispatch a field service engineer (fse) to go onsite to check the clinical audit trail for the alarm that customer claims was missed.The onsite service was canceled, because the fse troubleshot with the customer over the phone.Once the customer rebooted the monitor, it started working properly.The customer called the nurse over and tested the spo2, and the monitor was working normally.Based on the information available and the testing conducted, the cause of the reported problem is unknown, as the reboot resolved the issue, the cause was unable to be traced to one thing and is unknown.The reported problem was confirmed.The customer advised that the monitor is currently working normally.The investigation concludes that no further action is required at this time.

• Brand Name: INTELLIVUE MP70
• Type of Device: INTELLIVUE MP70
• 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: 18335571
• MDR Text Key: 330605650
• Report Number: 9610816-2023-00665
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862451
• Device Catalogue Number: 862451
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2007
• 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