MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS M3155 UPGRADE REL N.01; CENTRAL STATION MONITOR

Model Number M3155

Device Problem No Audible Alarm (1019)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 11/02/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer had questions about printing data for a patient in bed 3187p between hours of 17:00 to 18:00 on (b)(6) 2020.Further information received on 17nov2020 indicated the customer wanted to know if the alarms were silenced for an asystole.The patient coded, but lived.

Manufacturer Narrative

Type of complaint should be death.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

The biomed confirmed they were not alleging a product malfunction.According the biomed, the patient had gotten out of bed to use the bathroom, and the leads popped off.The attending clinicians were aware the leads had come off, but did not reattach the leads.This lasted around a half hour, and during this time, the patient had a vtach event, and passed away.The customer is looking to see if there is a record of anyone silencing alarms.A philips field service engineer (fse)went to the customer site and obtained philips intellivue information center (piic) log files for review.The log files were provided to a philips clinical product specialist (cps), who reviewed the logs.The cps found the piic data acquisition and junk.Dat files had written over due to their size and the length of time between the issue and the time files were obtained.There was no alleged product malfunction from the customer, and no malfunction was seen during review of available data.The customer was asking to see if someone had silenced alarms, however, data during the time requested for review was not available, as it had been overwritten.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: M3155 UPGRADE REL N.01
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10971421
• MDR Text Key: 220395876
• Report Number: 1218950-2020-07589
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2020

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: M3155
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 11/17/2020; 11/17/2020
• Supplement Dates FDA Received: 01/04/2021; 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening