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

Model Number 865350

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 04/25/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported a dnr (do not resuscitate) patient expired and no red alarm was seen or heard at central cmu (cardiac monitoring unit).The incident took place on sunday (b)(6) 2020 at 6:00pm.Additional information was requested; however, the customer stated they will not release any information until risk management investigates.

Manufacturer Narrative

Device evaluated by mfr: the returned device was evaluated by the product support engineer (pse).Examination of the device did not reveal any physical damage.Early stages of corrosion were noted at pin 4 (eeprom) and at ecg pin 6 (right leg).The corrosion noted would not impact connectivity and communication with the patient cable, or with ecg signal acquisition.Chemical residue was noted on the contacts in the battery compartment.The mx40 pwm logs were reviewed, which indicate there were no reboot events or losses of communication logged during the time the patient was being monitored.The device was put into standby mode at 17:32 on (b)(6)2020.It was reported the incident occurred at 18:00 on (b)(6)2020, the device was put into standby mode at 17:32 on (b)(6)2020; therefore, no monitoring was being performed for the 28 minutes leading up to the reported time of death.No measurements would be performed and no alarms would be generated while the device was in standby mode.When the device is put into standby mode, the message ¿telemetry standby¿ is displayed in the patient sector.The mx40 performed as specified.While no device malfunction was identified, the device was updated to the latest hardware and software the repair also included replacement of the rear housing, to resolve the noted corrosion issue.The device was returned 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: 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: 10046241
• MDR Text Key: 190597250
• Report Number: 1218950-2020-02757
• 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
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Weight: 112