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

Model Number M8007A

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 08/02/2016

Event Type  Death  

Manufacturer Narrative

The report of the alarms not going off was not supported by the monitoring data.There was no malfunction.The biomed tested the system and verified that alarms do go off at the mp70 in question and at the central station.A review of the alarm logs also showed several alarms at the time of the reported event, including instances of the alarms being silenced or suspended.The information from the alarm log was provided to the customer by a field service engineer, as requested.The device remains at the customer site, and no subsequent calls have been logged for this device/issue.No further investigation is warranted at this time.

Event Description

The customer reported that they had an "issue with the unit".The nursing staff claims an mp70 patient monitor, as well as the central station, didn¿t alarm.The staff was aware of the patient condition.Cpr was started at 19:11 and continued until 19:35 when the patient was pronounced.The staff was there and aware of each rhythm change and responded appropriately.

• 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: richa shah ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 5873046
• MDR Text Key: 52013271
• Report Number: 9610816-2016-00222
• 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
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• 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: 08/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2002
• 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: 68 YR
• Patient Weight: 141