MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX450 PATIENT MONITOR

Model Number 866062

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2022

Event Type  Death  

Event Description

The customers biomed reported that on (b)(6) 2022 at 6:40pm the patient was found unresponsive and cold.As the mx450 monitor was on the patient the customer wants to have checked if it was a factor in or contributed to the reported death.The device was reported to be in use on a patient, the patient expired.

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customers biomed reported that on (b)(6) 2022 at 6:40pm the patient was found unresponsive and cold.As the mx450 monitor was on the patient the customer wants to have checked if it was a factor in or contributed to the reported death.The device was reported to be in use on a patient, the patient expired.

Manufacturer Narrative

H6 updated some codes h10: a philips field service engineer (fse) went to the customer site.The fse collected the relevant alarm log from the philips intellivue information center (piic ix) and from the intellivue mx450 patient monitor for further evaluation.The responsible product support engineer reviewed available alarm log files from the intellivue information center (piic ix) and stated the following: the auditlog confirms that there were ecg, spo2 and pulse alarms.At 18:25:59 the ecg electrodes fell off, from then on only pulse alarms came.Active alarm from 18:25:02 to 18:29:16 was desat (red alarm), silenced on bedside monitor at 18:29:14.The product associated with the event was returned and evaluation/analysis was performed.The engineer was able to confirm the product was functioning as intended with no failures found.Device is fully functional and passed all performance verification test.

• Brand Name: INTELLIVUE MX450 PATIENT MONITOR
• Type of Device: INTELLIVUE MX450 PATIENT MONITOR
• 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: 13505239
• MDR Text Key: 285389469
• Report Number: 9610816-2022-00075
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038769
• UDI-Public: 00884838038769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 866062
• Device Catalogue Number: 866062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2015
• 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: 86 YR
• Patient Sex: Male