MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIIC IX HARDWARE; CENTRAL STATION MONITOR

Model Number 866424

Device Problems No Audible Alarm (1019); Disconnection (1171)

Patient Problems Death (1802); Fall (1848)

Event Date 08/14/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that they did not hear ecg or spo2 disconnect alarms at the central station for a patient that fell, and ultimately expired, around 17:00 on (b)(6) 2020.

Manufacturer Narrative

There was no product malfunction.This is considered a configuration issue, as the alarms did occur, but were set at a volume the user couldn't hear.The alarm volume for yellow and technical alarms was increased by the customer biomedical engineer to resolve the issue.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: PIIC IX HARDWARE
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10440492
• MDR Text Key: 203973007
• Report Number: 1218950-2020-04868
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838052130
• UDI-Public: (01)00884838052130
• Combination Product (y/n): N
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

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: 866424
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 08/22/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR