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

Model Number 865350

Device Problem Device Alarm System (1012)

Patient Problems Death (1802); Fall (1848)

Event Date 04/25/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, the customer reported that an asystole was missed when the transmitter was off-line.A nurse discovered that the patient had fallen off their bed (l5605-01).The nurse notified clinical engineering that no alarm conditions were indicated at the philips information center ix (pic ix) from the mx40 telemetry device connected to the patient.When asked whether the mx40 leads were ever disconnected from the patient, the answer was no.However, nursing stated they should have received an asystole alert for this bed.The patient expired four days after the date of incident.

Manufacturer Narrative

H3 and h6: a philips field service engineer (fse) went to the customer site.The fse tested the mx40, and found it was working with no issue and verified the connection to the nearest network access point (ap).The hospital's biomed confirmed that he had also tested the mx40 involved and verified it to be working properly.The fse obtained alarm logs from the pic ix for this incident in order to confirm if the mx40 sent an asystole alert for the bed during the time of event, which was verified to have occurred between 23:22pm-23:23 pm on (b)(6) 2020.The alarm log was reviewed by the philips product support engineer (pse) and a philips complaint investigator (ci).The pse observed a respiration rate alarm at 21:58.The ci observed an asystole alarm at 23:22:57.Additional alarms occurred from 23:22:49 through 23:31:18.These alarms were silenced and the asystole then ended at 23:31:31.Based on the investigation, the mx40 was determined to be working as intended.The investigation was provided to the customer.The device remains at the customer's 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.

Manufacturer Narrative

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: 10032461
• MDR Text Key: 190128806
• Report Number: 1218950-2020-02712
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2020

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: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 04/27/2020; 04/27/2020
• Supplement Dates FDA Received: 07/17/2020; 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR