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

Model Number M8007A

Device Problems Device Alarm System (1012); Disconnection (1171)

Patient Problems Cardiac Arrest (1762); Fall (1848)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.(b)(6).

Event Description

The customer reported that the patient in room 124 fell from their chair on (b)(6) 2017 around 13:18 and became disconnected from the monitor, but there was no bed-to-bed alarms.Technical inops did sound at both the bedside and the central station.It was reported that the patient suffered a cardiac arrest.

Manufacturer Narrative

The field service engineer (fse), was paged to contact the customer.Per communications with the fse, the customer does not feel that the device was a contributing factor in the patient incident because there were a lot of inop alarms occurring during the morning hours for the bed 124 and the nurse was aware of the behavior of the monitor.In addition, the nurses noted that they were in a meeting between 13:15 to 13:30 on (b)(6) 2017.A review of the logs provided indicate that a inop alarm occurred for loss of ecg connection at 13:18 and was resolved at 13:35.The bedsides were upgraded in 2015 by the customer since they have the intellivue support tool, and technical alarms were changed to red, however, this particular bedside involved was either missed or not changed by the customer.The customer changed the configuration of the monitor to match their other monitors of red technical alarms.No device malfunction occurred.

• 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: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 6297292
• MDR Text Key: 66388032
• Report Number: 9610816-2017-00024
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021300
• 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: 02/01/2017

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: M8007A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2004
• 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): Required Intervention