MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

Model Number M8007A

Device Problem Defective Alarm (1014)

Patient Problems Stroke/CVA (1770); Death (1802)

Event Date 03/24/2017

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the monitor did not announce a hr alarm.Per a nurse, the monitor showed the heart rate at 180bpm.No visual or audible alarms triggered, even though the high alarm limit was 170bpm.The incident occurred during patient monitoring around 12:02 on (b)(6) 2017 in the icu.The customer indicated that the patient had a stroke.The patient was transferred to palliative floor and passed.They do not feel that what happened in the icu had any effect on the patient outcome.

Manufacturer Narrative

Philips cannot rule out a malfunction of the device.The alarm logs from the central station were collected and reviewed by a philips product support engineer (pse).He stated that there was no indication for a hr/pulse alarm, based on the alarm history data.However, there was no proof that the alarm limit was set to 170.The customer has a profile of "comfort care" in which a hr limit of 200 is set; it is likely possible that this setting was used during the incident.Attempts to obtain information on the setting being used at the time of the reported incident were unsuccessful.During the evaluation of the device, the customer biomed performed simulation on the mp 70 and x2 monitor and found the equipment performing within specifications; the problem was not reproducible.With the available information, philips has not been able to establish exactly what happened at the time of the reported event, and therefore it was not possible to establish a clear cause.

Event Description

The customer reported that the monitor did not announce a hr alarm.Per a nurse, the monitor showed the heart rate at 180bpm.No visual or audible alarms triggered, even though the high alarm limit was 170bpm.The incident occurred during patient monitoring around 12:02 on (b)(6) 2017 in the icu.The customer indicated that the patient had a stroke.The patient was transferred to palliative floor and passed.However, they do not feel that the monitor contributed to the patient outcome.

• Brand Name: MP70 INTELLIVUE PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6485702
• MDR Text Key: 72548531
• Report Number: 9610816-2017-00109
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2006
• 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 Age: 65 YR