MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5

Model Number 865024

Device Problem Defective Alarm (1014)

Patient Problems Hypoxia (1918); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that this morning (b)(6) 2022 at 10:13 am in cubicle cmc5, a pni (sys) alarm would not have sounded.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

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

Event Description

The customer reported that this morning 08/12/2022 at 10:13 am in cubicle cmc5, a pni (sys) alarm would not have sounded.The device was in use on a patient.Patient became severely hypotensive and required resuscitation, it was indicated the alarm was not triggered when the systolic pressure dropped to 50; however, the monitor was configured to alarm with mean blood pressure as the priority.Based on this information the device functioned as intended.It was noted this patient was being monitored at end of life.According to this information, the philips device did not cause or contribute to this serious injury and functioned per configurations.

Event Description

The customer reported that this morning 08/12/2022 at 10:13 am in cubicle cmc5, a pni (sys) alarm would not have sounded.The device was in use on a patient.Patient became severely hypotensive and required resuscitation, functional testing/service repair/technical investigation: a philips remote service engineer (rse) interviewed the customer to evaluate the device in question.The following technical investigation was performed: the (rse) gathered the following alarm limits: the sys value was at 50 and only an average alarm rang.The alarm limit on the monitor: dias: 100/50; sys: 180/90; and average: 65.The mp5 logs were provided by the customer, which were forwarded to the philips product support engineering (pse) for analysis.During the investigation, the (pse) found the following: according to configuration file, the customer selected the sys&dia&mean alarm source.In this case the monitor will trigger only one priority alarm which was detected at the first stage (mean) and then generated only the mean alarm.The mean value was 43mmhg, lower than the set limit 43<65 mmhg and the unit alarmed.Furthermore, the rse indicated that the installation person was asked by the doctor to have the unit, "alarm nibp mean only and not syst/dyst.Based on the information available and the testing conducted, the cause of the reported problem was confirmed.It was indicated the alarm was not triggered when the systolic pressure dropped to 50; however, the monitor was configured to alarm with mean blood pressure as the priority.Based on this information the device functioned as intended based on the user's requested configuration.It was noted this patient was being monitored at end of life.According to this information, the philips device did not cause or contribute to this serious injury and functioned per configurations.

• Brand Name: INTELLIVUE MP5
• Type of Device: INTELLIVUE MP5
• 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, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 16013616
• MDR Text Key: 305977229
• Report Number: 9610816-2022-00640
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,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: 865024
• Device Catalogue Number: 865024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/16/2023; 02/21/2023
• Supplement Dates FDA Received: 02/09/2023; 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• 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): Life Threatening