MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem Defective Alarm (1014)

Patient Problem Death (1802)

Event Date 02/25/2020

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.The patient was found with a flat line on the monitor at 01:06 hours.The hospital's biomed manager was contacted by the philips southeast district service manager for additional event details.The hospital's biomed manager advised that this was not an equipment issue as he acquired a printout that documented the alarms for the asystole event.The biomed stated he informed the staff that if the alarm/ event appeared on the document, then it appeared on the screen.The hospital's biomed manager advised this was a training issue as they recently acquired new staff in the central monitoring area.

Event Description

An attorney representing the hospital reported that a patient died on (b)(6) 2020 after a 48 minute asystole incident at approximately 00:02 hours while on the telemetry device.The device was being monitored by the hospital monitor technicians and the hospital monitor technicians reported that no alarming occurred.

Manufacturer Narrative

H3 and h6: the device was not expected to be returned for evaluation and the hospital's biomed declined the offer to have a philips field service engineer (fse) go on site to pull logs for review by a philips engineer.Therefore, the alarms were not confirmed by a philips engineer.The hospital's biomed manager advised that this was not an equipment issue as he acquired a printout that documented the alarms for the asystole event.The biomed stated he informed the staff that if the alarm/ event appeared on the document, then it appeared on the screen.The hospital's biomed manager advised this was a training issue as they recently acquired new staff in the central monitoring area.The hospital's biomed declined the offer to have a philips field service engineer (fse) go on site to pull logs for review by a philips engineer.The device was not taken out of service.The device remains at the customer site.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: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10087964
• MDR Text Key: 192019652
• Report Number: 1218950-2020-03072
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: (01)00884838082236
• Combination Product (y/n): N
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 05/19/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR