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

Model Number M8007A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/26/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that a patient who was lying in bed 8, stood up and ripped out all of the cables, electrodes and the related measuring instruments.An alarm was not forwarded to the control center.The incident happened on (b)(6) 2018 between 9:00 pm and 9:29 pm (time of death).The patient died.

Manufacturer Narrative

Although the reported malfunction of the alarm not being forwarded to the control center, could not be reproduced, the exact cause for the reported issue remains unknown and philips cannot rule out a malfunction at the time of the incident.All patient related data, such as alarms and parameter data, were deleted from the bedside monitor by the personnel; therefore, it is not possible to see if inop alarms had occurred on the bedside monitor, when the patient disconnected the cables.A philips response center engineer (rce) obtained alarm audit logs from the control center (piic classic) used with the bedside monitor.A gap in the alarm log for this bed was seen between 17:11:34 and 21:21:35 on (b)(6) 2018.The customer indicated that the patient had "ripped out" all of the cables, which would cause inop alarms.As the piic classic used by the customer only records high level red alarms, if this were to have occurred, the alarm log would not show information during the time the cables were disconnected.Beginning at 21:21:35, multiple high level red alarms, including asystole and apnea alarms, were activated, and acknowledged (suspended).The device was tested by a philips field service engineer (fse), and the malfunction, alarm not forwarded to the control center, could not be reproduced.All alarms were adjusted and verified with a patient simulator; the alarms behaved as expected.The monitor reacted correctly in all scenarios, and all alarms were also forwarded to the control center.No parts were ordered and no repair was warranted.The device remains at the customer site, and there have been no subsequent calls logged for this device/issue.No further investigation is warranted at this time.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• 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
• MDR Report Key: 8114665
• MDR Text Key: 128721764
• Report Number: 9610816-2018-00333
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

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: M8007A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR