MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE INFORMATION CENTER; CENTRAL STATION

Model Number M3150

Device Problems Device Alarm System (1012); Loss of Power (1475)

Patient Problem Death (1802)

Event Date 01/29/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that at 5:19 am on (b)(6) 2018 they had a telemetry device shut off (telmed3) in room 142.The night shift was in the room at 6:18 and found that the patient had expired.The night staff indicated that they did not hear an alarm at the central station (piic) to warn them of the patient's condition.The patient was found expired in their room.The customer identified the issue was found during a time that a patient was being monitored at the central monitor on the clinical unit by a 862231 telemetry transceiver.

Manufacturer Narrative

A philips field service engineer (fse) went on-site to evaluate the device and to collect log files and strips for review.Testing of the device found alarms were provided for simulated alarm events.Logs and strips were sent f or evaluation by quality and research and development staff.Per the information provided the issue is most consistent with a leads off condition at (b)(6) 2018 at 5:28:58 where the device turned off at 5:39:17 due to the rf auto shutoff feature.Rf auto shutoff shuts off the device after 10 minutes of all leads off and no spo2 sensor attached.Per the logs the bed label was ch142 and the equipment label was telmed8: telmed3 was not monitoring during the time in question per software development engineering.Per the pdsstore log files the device was activated again (monitoring again) at 06:22:26."ecg leads off" is a hard technical alarm where monitoring and alarm generation are disabled.There is a visual alarm indicator on the mx40 and an audible tone at the information center as well as a ¿leadset unplugged" alert.This inop may also be configured to display as a red or yellow technical alarm.The "ecg leads off" inop will initially display as a cyan technical alarm at the central station until a valid ecg signal is obtained."transmitter off" ( rf auto shutoff) is a hard technical alarm where monitoring and alarm generation are disabled.There is a visual alarm indicator on the mx40 and an audible tone at the information center.The results of the investigation were provided to the customer via formal letter of response.No parts were replaced.No device malfunction occurred.The investigation has demonstrated that alarms were provided at the time of the event for "leads off" and "transmitter off".Testing found the device performing to specification.

• Brand Name: INTELLIVUE INFORMATION CENTER
• Type of Device: CENTRAL STATION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7245333
• MDR Text Key: 99147339
• Report Number: 1218950-2018-01344
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

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: M3150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 02/02/2018
• Supplement Dates FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2009
• 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