MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS V24/26 COMPONENT MONITORING SYSTEM; BEDSIDE MONITOR

Model Number M1205A

Device Problem Defective Component (2292)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.Additional information has been requested.

Event Description

On (b)(6) 2018 it was reported that a philips m1205a monitor malfunctioned.The device was being used to monitor a patient.The patient passed away.

Manufacturer Narrative

Additional information (t-alarm review from the bed, available strips, alarm history of monitor & central station (if connected), alarm logs of the central station (if connected), sw version of the used monitor, device report) was requested for the investigation and evaluation of the reported issue.However, no additional information requested by philips was received.Philips quality & regulatory manager,ma complaint operations (q&r manager) reviewed the reported issue and stated that this complaint is related to a lawsuit against the hospital.In addition, (q&r manager) stated that there was conflicting information regarding the product number involved: lawsuit indicated m1204a and reported issue indicated m1205a.Quality & regulatory supervisor, philips taiwan ltd (q&r supervisor) reviewed the reported issue and confirmed that taipei health bureau (competent authority) informed philips office about a citizen who complained about the device malfunction on october of 2018.Alleged product could not be located in the installed base (ib) and importation records could not be referred within philips.Q&r supervisor confirmed that the reported information has been filed with competent authority in november of 2018.Since then philips did not receive any further questions from competent authority.Investigation of the reported issue was not possible due to lack of available information.

• Brand Name: V24/26 COMPONENT MONITORING SYSTEM
• Type of Device: BEDSIDE MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 7734337
• MDR Text Key: 115517886
• Report Number: 9610816-2018-00186
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• PMA/PMN Number: K002758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M1205A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 07/02/2018
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other