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

Model Number 862451

Device Problem Defective Alarm (1014)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.Reporting address state: (b)(6).Reporter phone #: (b)(6).

Event Description

The customer reported a recurring problem of desaturation of the patient without an alarm.The customer indicated that the alarm was present on the monitoring central station, but not on the monitor of the room.A test was performed by a customer biomedical technician with a patient simulator, and the device was operational.Additional investigation was requested.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient reported.

Manufacturer Narrative

Information indicated this event occurred on (b)(6) 2024, between 3:20 p.M.And 3:30 p.M.In room 6.A philips 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.The reported problem was not confirmed.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.H3 other text : customer performed testing.

• 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: 18824983
• MDR Text Key: 336751238
• Report Number: 9610816-2024-00116
• 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: Health Professional,User Facility,Company Representative
• 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
• Device Operator: Health Professional
• Device Model Number: 862451
• Device Catalogue Number: 862451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1