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

Model Number 862451

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem Insufficient Information (4580)

Event Date 08/22/2021

Event Type  Death  

Event Description

The customer reported their mp70 intellivue patient monitor failed to generate a respiratory (resp) alarm.The device was in use on a patient, the patient died and no further information regarding the reported issue were available at the time of the reporting decision.

Manufacturer Narrative

A philips remote clinical application specialist (rcas)service engineer (rse) spoke to the customer.The engineer determined that the issue was associated with the respiration measurement/parameter being turned off at the bedside monitor.The manager at the customer site indicated the problem was with the patient¿s external ventilator and not the philips monitor.The device was working as intended with no failures found, as it was determined by the rcas that the respiration measurement/parameter was turned off at the bedside monitor.

Event Description

The customer reported their mp70 intellivue patient monitor failed to generate a respiratory (resp) alarm.The device was in use on a patient, the patient died and no further information regarding the reported issue were available at the time of the reporting decision.

• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12378979
• MDR Text Key: 268519726
• Report Number: 9610816-2021-10320
• 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: 08/27/2021
• Is this an Adverse Event Report?: Yes
• 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
• Distributor Facility Aware Date: 08/23/2021
• Date Manufacturer Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2009
• 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): Death
• Patient Age: 89 YR