MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP20

Model Number 862134

Device Problem False Alarm (1013)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

The customer reported no valid alarm during cardiac arrest coming from the device.The device was in use at time of event, a cardiac arrest of the patient was reported.

Manufacturer Narrative

Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.(b)(6).

Event Description

Philips received a complaint on the intellivue mp20 indicating the patient had more than 3 seconds of cardiac arrest on the night of 8.22.There was no accurate three-star alarm when the patient had a cardiac arrest signal.The unit had only alarmed the three-star alarm bradycardia.The customer reported the settings could not be changed.The device was in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.Patient was responding well.

Manufacturer Narrative

A philips field service engineer (fse) went onsite to evaluate the device and confirmed the monitor was configured for the asystole threshold of 4 seconds cardiac arrest.Because the threshold was not actually configured, the monitor only generated a yellow cardiac arrest alarm.The fse reported there was customer's misunderstanding of the monitor setting, and there was no actual problem.The cause of the reported problem was confirmed to be a customer's misunderstanding of the monitor settings.There was no actual problem.The device remains at customer site.

• Brand Name: INTELLIVUE MP20
• Type of Device: INTELLIVUE MP20
• 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: 17718878
• MDR Text Key: 323054094
• Report Number: 9610816-2023-00454
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122439
• 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

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: 862134
• Device Catalogue Number: 862134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 11/16/2023
• Date Device Manufactured: 11/29/2013
• 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