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

Model Number 862451

Device Problem No Audible Alarm (1019)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/23/2021

Event Type  Death  

Event Description

It was reported on (b)(6) 2021 the spo2 alarm was turned off and the clinical staff was not aware of a critical desaturation alarm.The device was in was reported to be in use on a patient, the patient passed away.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

A philips clinical application specialist (cas) spoke to the customer.During the investigation it was found that the clinical staff had turned off the spo2 alarm, which resulted in the failure to alarm for the desaturation event.Audits at the customer site revealed that the clinical staff was continuing to turn off alarms despite practice alerts and education.The customer requested an enhancement in the alarm configuration for all parameters that would allow to disable the feature that enabled the clinical staff to turn alarms off on each measurement.The enhancement request was forwarded to philips research and development (r&d) for consideration for a future release of the monitors.Additionally, philips reviewed the alarm behaviors and the monitor configurations with the customer and has provided clinical education.

• 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: 13061816
• MDR Text Key: 282632703
• Report Number: 9610816-2021-10561
• 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

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2005
• 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: 70 YR
• Patient Sex: Female