MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 2.4 GHZ SMART HOPPING

Model Number 865351

Device Problems Device Alarm System (1012); No Display/Image (1183); Connection Problem (2900)

Patient Problem Death (1802)

Event Date 03/09/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that there was a failure to alarm for a mx40 device as there was a connectivity problem with the central station so that there was no patient data being displayed at the central station before the adverse patient incident.It was reported that the patient expired.Further investigation is needed to understand if the device caused or contributed to the patient event.

Manufacturer Narrative

Philips obtained the data logs from the piic (philips intellivue information center) from the customer's biomedical engineer.  data logs were reviewed a clinical specialist, quality investigator and r&d (research and development) engineer.The investigation was limited due to the timing on the collection of the piic data logs which were not collected until 3/23/2017 when the issue was reported to philips.  stored data from the time of the event on (b)(6) 2017 was no longer available on some of the data logs provided.  no strips or stored data were provided as the customer stated that a patient report was printed and the patient was discharged with all data deleted and the patient report (paper) was lost.    data logs collected show that the mx40 was alarming for ***asystole red alarm from07:15:05 through 07:15:43.   additional information provided stated that a physician checked the hr on the telemetry device in question at 12:30 pm and also checked the power by pressing the blue button on the mx40, indicating that battery was working at this time.A nurse tested the tele15 (telemetry device used at the time of the event) later in the afternoon (no time specified) in parallel with another mx40 (both with connected ecg) and found that tele15 showed dropouts (<1min) and the other tele (telemetry not in use at the time of the event) showed no dropouts.Data log evaluation did find that the device was frequently losing connection and reconnecting throughout the day on (b)(6) 2017.  without complete data logs provided for activity on 3/9/2017, philips cannot conclude the reason for the loss of connection.  philips can confirm that the device was connected to the piic for bed f5 from 10:56 ¿ 13:33 with no disconnects on (b)(6) 2017, although no alarming could be confirmed.  the mx40 telemetry device was not returned to philips for evaluation or tested by philips at the customer site, therefore no conclusions can be made.  without a complete understanding of the event including all logs, wave strip exports, alarm settings, device logs and device evaluation, philips cannot determine the cause of the reported issue.  an ecg leads off, inop (inoperative) message (dependent on configurable alarm severity, red, yellow, or cyan) may have been in effect, however insufficient information was provided to conclude that was the case.  the customer has been provided a review of the available data.  it is unknown if the device is in use at the customer site.The cause for the failure to alarm for asystole and the disconnection issues cannot be determined with the information provided as the log data was incomplete and patient strips were not provided.Use of the device is considered to be a factor as the customer said the patient was deteriorating before the asystole alarm occurred and staff were not aware.Philips will consider that the ecg alarming may have been impacted by a leads off alarm at  the time of the event thereby preventing ecg alarms,  however insufficient information was provided to make that determination.A malfunction preventing ecg alarming cannot be ruled out.

Event Description

It was reported that there was a failure to alarm for asystole on (b)(6) 2017 in bed f5 (telemetry label 15) sometime after 7:15 am for a mx40 device with a connectivity problem with the central station, so that there was no patient data being displayed at the central station before the adverse patient incident around 13:00 hour.The patient was transferred to icu (intensive care unit) after resuscitation attempt.The patient subsequently died.

• Brand Name: MX40 2.4 GHZ SMART HOPPING
• Type of Device: MX40 2.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6438450
• MDR Text Key: 70971606
• Report Number: 1218950-2017-01971
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR