MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP50

Model Number 862116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyanosis (1798); Insufficient Information (4580)

Event Date 02/08/2022

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.

Event Description

Biomed called to request fse onsite to pull the logs of the bedside monitor.There was a patient incident on (b)(6) 2022.The monitor has not been used since the incident.It was reported there was a patient incident resulting in harm; however, there is insufficient information to determine the type of harm or whether the harm was related to a philips device.

Manufacturer Narrative

The field service engineer (fse) went onsite and assisted in pulling the logs of the bedside monitor.The customer learned to pull all the logs.A review of monitor activity was performed, revealing anesthesia had silenced the alarms.It was indicated by the customer that the device appeared to be functioning properly and the reported issue was entirely due to use error.The risk management department at the hospital indicated: "this case seems to be a direct result of a lack of medical care under the anesthesiologist's watch and not due to a pre-existing condition." this information supports the conclusion that the device function did not cause or contribute to the reported event.Based on the information available and the testing conducted, the cause of the reported problem was the user, and there was no malfunction of the device.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.

Event Description

Philips received a complaint on the intellivue mp50 indicating that the customer wanted all logs pulled from the monitor.There was a patient incident on (b)(6) 2022, and the monitor had not been used since the incident.During a routine procedure while monitoring anesthesia, the patient became cyanotic, requiring resuscitation. the patient was moved to a higher level of care due to a cerebrovascular accident (cva) and has some residual deficits, which require rehabilitation.

• Brand Name: INTELLIVUE MP50
• Type of Device: INTELLIVUE MP50
• 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: 18132645
• MDR Text Key: 328067795
• Report Number: 9610816-2023-00580
• 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
• 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: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862116
• Device Catalogue Number: 862116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2007
• 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): Required Intervention; Other