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 10/08/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017, the customer notified the customer care solutions center (ccsc) that they are questioning the accuracy of the clinical audit trail and were trying to determine whether or not an abp alarm sounded appropriately for a patient that expired on (b)(6) 2017.The patient expired.

Manufacturer Narrative

The customer described that the patient was admitted on october 2nd and expired on (b)(6) at 2:41 am.The patient had become acutely hypotensive with increasing vasopressor requirements and had a subsequent loss of pulse and perfusing rhythm resulting in death.One staff member said they thought they noticed on the monitor display at one point in time that the abp alarm was off.Another staff member said the arterial line had been positional the day before and they had paused or silenced the alarms several times but did not see evidence of this in stored log data.Onsite evaluation of the device was performed by a philips field service engineer (fse) who confirmed that the monitor was operating as specified during testing.A review of the logs and the configuration found that the alarms were configured to alarm for a systolic bp and the last abp alarm was on (b)(6) at 21:29.The logs do not store any alarm on/off actions taken for invasive pressure as confirmed by clinical product specialist (b)(6).It is important to note that the abp high alarm limit was 150 on the 7th at 00:00 but was changed during the course of the day to 160, 165 and 175 at various times.The low limit was set at 80.The logs support that multiple abp alarms were occurring on the 7th with alarms silencing occurring.Most abp alarm were high limit violations but there were several low limit violations.Alarms were also paused several times on the 7th.It is clear from the logs that changes in the patient condition were occurring shortly after 2:00 am on the 8th with ***desat, ***vent fib/tach, ***asystole, ***vtach and ***apnea alarms occurring.The device was removed from service during the investigation and the customer has been provided with information about the investigation.Testing found the device operating per specification.The device remains at the customer site.It is not known if the customer has now returned the device to service or not.The investigation finds the issue is not consistent with a malfunction of the device.The customer indicated that they believed the alarm for abp may have been turned off which would prevent any abp related alarms from occurring once the alarm had been disabled.Based on a review of the provided data and onsite testing of the product, the product performed as designed and provided multiple alarms for a variety of changes in the physiological condition of the patient.The absence of abp alarms after 21:29 on (b)(6) aligns with the customer's statement that one user thought they saw the abp alarm was off.No further action or investigation is warranted at this time.The use of the device is considered to have been a factor in the incident as staff indicated they had not been alerted to the change in blood pressure.

• 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: 7110374
• MDR Text Key: 94579559
• Report Number: 9610816-2017-00392
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2010
• 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: 59 YR
• Patient Weight: 109