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

Model Number 866424

Device Problem Loss of Power (1475)

Patient Problem Death (1802)

Event Date 11/04/2020

Event Type  Death  

Manufacturer Narrative

Date of incident has been requested, not available at time of report patient information requested, not available at time of report.A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that a generator test caused a power loss during which time a patient expired.

Manufacturer Narrative

A philips field service engineer (fse) was dispatched for onsite service.The investigation determined that the customer was advised of uninterruptible power supply (ups) issues in advance of the reported event on (b)(6) 2020.The issues included the requirement to replace batteries and the identification of faulty ups units.As the maintenance of the ups units falls under the responsibility of the customer, information only was provided at the time of the original assessment.During the generator test, ups unit failed to provide power and patient data did not come across server.There was no product malfunction; this is considered a user issue.The fse performed an assessment of the ups units at the customer site and a detailed report was provided to the customer.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: 10876337
• MDR Text Key: 217414864
• Report Number: 1218950-2020-07072
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• 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
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death