MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC INTELLIVUE MX40 802.11A/B/G

Model Number 865352

Device Problem Alarm Not Visible (1022)

Patient Problem Death (1802)

Event Date 02/20/2021

Event Type  Death  

Event Description

It was reported that on (b)(6) 2021 the patient's heart rate was being monitored by the mx40.During a control round on (b)(6) 2021 at 00:30 o'clock, the patient had been asleep and had been inconspicuous.At 3:30 am on this day, the patient was found lifeless, lying supine on the floor.The "heart alarm" was immediately triggered and the person who found the patient immediately started cardiac massage.A team from the emergency room arrived promptly and took over the resuscitation measures.Up to this time, no alarm had been released by the telemetry monitoring.After termination of the resuscitation a determination of death (03:50 o'clock) was pronounced.A nurse on night duty was able to determine that from around 01:00 hours, no more data had been transmitted from the mx40.The nurse was not able to determine whether or how the electrodes of the mx40 were attached to the patient at the time he was found, however it was confirmed the mx40 had been with the patient when he was found.The nurse mentioned to the cid that the mx40 briefly reported a "blue alarm" - "electrodes off" message.This appeared only briefly and then did not occur again.The nurse was not sure about the time this alarm occurred.

Manufacturer Narrative

The philips field service engineer (fse) secured log files to include clinical audit log, rfda, and device debug log.The fse also obtained a picture of the wave review information entitled ¿ekg.Jpg.¿ our philips product support engineer (pse) reviewed the clinical audit log, rfda log, device debug log, and the ekg.Jpg image.Clinical audit log review: the pse¿s review of the clinical audit log confirms that there was an ecg leads off condition/ alarm at 01:03:17 am on (b)(6) 2021.The log also shows the alarm was silenced by a user at 01:05:55 am on (b)(6) 2021.This indicates that a user was aware of the ecg leads off alarm condition.There is no evidence of the leads off condition being resolved.Page 53 of the intellivue mx40 instructions for use (ifu) states this inop means, ¿multiple leads are off.¿ to resolve this issue, the ifu advises to ¿re-attach ecg leads to patient.¿ a ¿tele batt empty¿ inop was also generated and displayed at 03:47:55 am on (b)(6) 2021.The device shut down at 4:01:04 am on (b)(6) 2021.The patient was discharged at the pic at 04:15:55 am on (b)(6) 2021.Rfda log review: the pse¿s review of the rfda log confirms it does not show any loss of communication with the pic in or around the incident timeframe.The rfda log reflects the time the device shut down at 04:01:04 am on (b)(6) 2021.Device debug log review: the pse¿s review of the device debug log confirms it does not show any loss of communication with the pic in or around the incident timeframe.¿ekg.Jpg¿ image review: the pse¿s review of the screen picture of the wave information shows the loss of ecg monitoring at 01:03 on (b)(6) 2021 due to an ecg leads off condition, and that the condition persisted until at least 04:00 on (b)(6) 2021 (based on the time frame captured in the picture).The pse determined there was no evidence that there was a loss of communication (and therefore alarms) between the mx40 and pic in and around the incident timeframe.Therefore, the pse determined the telemetry device sent data to the central station (pic) and the pic analyzed the data and generated alarms.The alarms were silenced by a user at the central station.Based on philips¿ review of the above-described images and logs, the devices were determined to be working as designed.The investigation was provided to the reporter.The device remains at the customer site.

Event Description

It was reported that on (b)(6) 2021, the patient's heart rate was being monitored by the mx40.During a control round on (b)(6) 2021 at 00:30 o'clock, the patient had been asleep and had been inconspicuous.At 3:30 am on this day, the patient was found lifeless, lying supine on the floor.The "heart alarm" was immediately triggered and the person who found the patient immediately started cardiac massage.A team from the emergency room arrived promptly and took over the resuscitation measures.Up to this time, no alarm had been released by the telemetry monitoring.After termination of the resuscitation a determination of death (03:50 o'clock) was pronounced.A nurse on night duty was able to determine that from around 01:00 hours, no more data had been transmitted from the mx40.The nurse was not able to determine whether or how the electrodes of the mx40 were attached to the patient at the time he was found, however it was confirmed the mx40 had been with the patient when he was found.The nurse mentioned to the cid that the mx40 briefly reported a "blue alarm" - "electrodes off" message.This appeared only briefly and then did not occur again.The nurse was not sure about the time this alarm occurred.

• Brand Name: INTELLIVUE MX40 802.11A/B/G
• Type of Device: INTELLIVUE MX40 802.11A/B/G
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11381150
• MDR Text Key: 233690785
• Report Number: 1218950-2021-10027
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838030350
• UDI-Public: 00884838030350
• Combination Product (y/n): N
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 865352
• Device Catalogue Number: 865352
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/22/2021
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death