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

Model Number M8007A

Device Problem Incorrect Measurement (1383)

Patient Problem Death (1802)

Event Date 07/12/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

The hospital's biomed reported to a clinical application specialist (cas) that during the surgery, the doctor in charge was not able to make the right medical decision due to invasive blood pressure measurement issues.The biomed explains that during the surgery, they first observed a strange looking abp wave, which he explained on the phone as two peaks in the wave at the same size.They can also see on the piic ix central station that they have several waves with triple peaks.When the picco measurements are done, the doctor in charge felt like two of the measurement, the cvv and svv differed too much to be correct.Therefore the doctor in charge wasn't able to make any medical decisions based on the invasive blood pressure curve, invasive blood pressure measurements or the picco measurements.The patient died.

Manufacturer Narrative

The reported problem was investigated via remote clinical application specialist.The customer stated that the invasive blood pressure curve has a strange look and the picco values differ too much to be correct.The patient died because the physician was unable to make a decision how to treat with the given information.The customer provided log files and a screenshot of the invasive blood pressure waveform.The waveform appeared continuously.The waveform was reviewed by product support engineering, r&d and the clinical liaison specialist / clinical consultant, who stated that this kind of waveform resembled a pressure waveform in a patient in shock with vasoconstriction.R&d established remote connection to the customer's central station to review patient data to identify abnormalities which could cause or contribute to the event.The shown waves for the event were correctly displayed compared with the measured values.It was determined that a non-optimally placed catheter could have caused or contributed to the event.Further was reported that the calibration values necessary for picco measurement were not present.A question mark was displayed instead of values.This occurs if the calculation was not completely successful.The customer observed that the cvp (central venous pressure) parameter was greyed out indicating that it was not available or not ready (e.G.Expired calibration).The customer resolved the problem by selecting a different cvp curve.Patient conditions as well as measurement set-up has an influence on the values calculated, therefore a statement cannot be given if the calculations and described deviations were incorrect as the physician stated.The customer did not request a technical device check or report product faults on the device.The exact cause for the reported issue could not be established based on the provided information.The customer was advised of the investigation results by letter.The product remains at the customer site.During evaluation no product fault was identified.During testing, the device worked as intended and the exact cause for the reported issue could not be established.Pressure wave and picco values were displayed.No indication of incorrect measurement's was observed during evaluation.Additionally, the available information from this report does not support that this failure represents a systemic, design, or labeling problem.No further investigation or action is warranted.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: 7697601
• MDR Text Key: 114277608
• Report Number: 9610816-2018-00174
• 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: 07/12/2018

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: 07/12/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death