MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE INFORMATION CENTER; CENTRAL STATION

Model Number M3150

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 06/15/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported a patient¿s invasive blood pressure dropped to 30mm hg at approximately 20:20 hours and they wanted to review the logs at their philips intellivue information center (piic) regarding the status of the alarms during this timeframe.It was reported the patient expired.

Manufacturer Narrative

H3 and h6:the piic audit logs were provided to a philips clinical product specialist (cps).It was determined that 57 red alarms occurred from 8pm-9pm, but no blood pressure alarms were noted.As this involves a piic classic, the audit logs do not show the alarm as on or off.It is noted the recorder log was empty, so no automatic alarm recording was logged either.Csp advised obtaining the specific bed label and bedside configuration file for further analysis, as there is an extreme pressure red alarm that can be enabled, but may not have been on.Without the extreme pressure red alarm, blood pressure alarms are yellow and would not show in the red audit log.The audit log excerpt is as follows: the bed label and bedside configuration file were requested from the customer.The customer replied stating they do not believe the piic classic caused or contributed to the patient¿s death and did not question the proper functioning of the bedside monitor or piic classic.Customer resolution and conclusion the malfunction could not be confirmed.The bedside configuration file was not provided for further analysis.Therefore, it cannot be determined if the blood pressure alarm was on or off before, during, or after the incident.This information was relayed to the customer.No subsequent calls were noted.The device remains in use at the customer¿s site.No further investigation or action 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: INTELLIVUE INFORMATION CENTER
• Type of Device: CENTRAL STATION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10183580
• MDR Text Key: 196067207
• Report Number: 1218950-2020-03606
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K081983
• 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: 06/16/2020

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: M3150
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 06/16/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 61