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

Model Number 862134

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem Atrial Fibrillation (1729)

Event Date 04/19/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported their intellivue mp20 patient monitor failed to alarm for an event that occurred on (b)(6) 2021, between 06:20am and 06:50pm.The patient had constant atrial fibrillation.It was reported the patient had deceased.

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site and performed tests on the monitor using an ecg simulator which did not show any anomalies.By simulating red and yellow alarms, both the bedside monitor and the pic ix responded correctly.There was no product malfunction.The available information and investigation findings support that there is no design, manufacturing, materials or labeling problem, therefore no further investigation, action or communication is warranted.There have been no subsequent calls logged for this device / issue.The device remains at the customer site.

Event Description

The customer reported their intellivue mp20 patient monitor failed to alarm for an event that occurred on (b)(6) 2021, between 06:20am and 06:50pm.It was reported the patient had deceased.

• 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
• MDR Report Key: 11820847
• MDR Text Key: 250513464
• Report Number: 9610816-2021-10124
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K122439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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: 862134
• Device Catalogue Number: 862134
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/10/2021
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR