MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MULTI MEASUREMENT SERVER X2; PATIENT MONITOR

Model Number M3002A

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

Patient Problems Death (1802); Hematoma (1884); Hemorrhage, Subarachnoid (1893); High Blood Pressure/ Hypertension (1908); Irregular Pulse (2469)

Event Date 07/21/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

Via medwatch mw5095852, the customer reported that on (b)(6) 2020, a patient was admitted to the icu due to grade 5 subarachnoid hemorrhage.A ventriculostomy drain was placed and throughout the day, the patient had high/abnormal blood pressures with very narrow pulse pressures.The patient had a subdural hematoma (sdh) and a cardene infusion was being titrated according to the non-invasive blood pressure (nbp) cuff measurements.Around 14:00, the patient went into asystole and passed away shortly after.

Manufacturer Narrative

The customer reported that the intellivue multi measurement server x2 was used in companion mode with an intellivue mp70 patient monitor to measure the patient's vitals, including the non-invasive blood pressure (nbp) measurement.Per the customer, the values obtained for the nbp measurement were consistently high.To verify the performance of the device, the x2 was used on a nurse to measure the nbp, using the same nbp cuff as on the patient.A reading of 144/122 mmhg was obtained, with the values being 116/70 mmhg when verified with another device.The onsite biomed was then called and the x2 was handed over for additional testing.As the device was handed over to the biomed some time after the patient event, no further details were available whether any inop was displayed on the device at the time of the reported event.It is unknown how the customer resolved the reported issue.Based on the information provided, the exact cause for the reported issue could not be established and a malfunction of the device cannot completely be ruled out.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: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 10655513
• MDR Text Key: 210604450
• Report Number: 9610816-2020-00367
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K071426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

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: M3002A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death