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

Model Number 862451

Device Problem Device Alarm System (1012)

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

Event Date 02/05/2024

Event Type  malfunction  

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.Reporting address state: (b)(6).

Event Description

The customer reported desaturation of the patient without an alarm.An alarm present on the monitoring central station but not on the monitor of the room.A test was performed by a biomedical technician with a patient simulator: the whole is operational.The device was in use on a patient at the time of the event.There was no adverse event or patient reported.

Manufacturer Narrative

Several good faith effort attempts were made to determine the actual product and serial number for this event, however the information could not be obtained.This record is logged against the mx750 bedside monitor which was the likely device used at the time of this event.The 510k information documented is based on this product.The is related to mfr report number 9610816-2024-00116 reported at the same time.If additional information is made available, a supplemental report will be sent.A remote service engineer (rse) sent the biomedical engineer (biomed) the procedure to get the logs.The rse called the customer back to follow up, and the biomed told the rse that he was unable to pull the logs, but there was no problem with alarms.The biomed performed a test with a patient simulator, and the device was operational.The biomed was unable to reproduce the initial reported issue.The biomed requested to have the users trained properly on the alarming of the x2 and x3 of the unit.Philips was unable to replicate the reported problem.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.As the device was confirmed to be operating per specifications and no failure was identified, 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: 18864371
• MDR Text Key: 337356691
• Report Number: 9610816-2024-00136
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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