MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS M3145 RELEASE N.01 UPGRADE; CENTRAL STATION MONITOR

Model Number M3145

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 09/05/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer called for assistance retrieving logs for a patient on bed (b)(6) on (b)(6) 2018 14:00 to (b)(6) 2018 23:00.The customer wanted to review alarms.The device was in use monitoring a patient and the patient expired.

Manufacturer Narrative

Per communications with the rce, there was no device testing performed and/or on-site service.The biomedical engineer indicated that the device was not a factor in the patient death and there was no allegation of device malfunction.It is not clear if there were concerns over alarms/alarm handling.A review of the piic alarm logs for bed ch14 on (b)(6) 2018 between 14:00 to 23:00 found several spo2 and desat alarms, some of which were suspended, as well as numerous various inops indicating inadequate signal for spo2 and arterial artifact.The available information does not support a device malfunction.This will be considered a user alarm handling issue.The device remains in use at the customer site.

• Brand Name: M3145 RELEASE N.01 UPGRADE
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7886705
• MDR Text Key: 120644870
• Report Number: 1218950-2018-07388
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: M3145
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/18/2018
• Supplement Dates Manufacturer Received: 09/06/2018
• Supplement Dates FDA Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2013
• 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
• Patient Outcome(s): Death