MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP30 INTELLIVUE PATIENT MONITOR; COMPACT PATIENT MONITOR

Model Number M8002A

Device Problems Improper or Incorrect Procedure or Method (2017); Connection Problem (2900)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer called philips to report that, on (b)(6) 2020 around 23:45 pdt, a standalone mp30 bedside monitor was moved from another room to be used on a patient in a negative pressure room, where doors are closed.The customer swapped the monitor and plugged in the ethernet cable without checking/testing the configurations, without knowing it was a standalone monitor, and without entering the patient demographics / admitting the patient.The central station displayed ¿no data on monitor,¿ but the patient coded while connected to the standalone mp30, and no alarms were heard at the central station due to a lack of connection.

Manufacturer Narrative

Philips has confirmed that no product malfunction has occurred.The customer stated that no product malfunction of the mp30 has been alleged and that the piic ix was showing the ¿no data mon¿ inop in the associated sector.The customer also stated that the mp30¿s ethernet cable was plugged in without checking/testing the configurations, without knowing it was a standalone monitor, and without entering the patient demographics / admitting the patient.The customer has reported that after the patient coded, they successfully administered cpr to the patient.Following the patient event the customer informed philips that the patient was further hospitalized in the icu, last seen on (b)(6)2020.Philips does not know the status or outcome of the patient after (b)(6)2020.The customer informed philips that an evaluation and/or repair of the mp30 was planned, however, as of today, (b)(6)2020, philips does not know the status of the mp30 after (b)(6) 2020 and has not received a product return or evaluation request for the mp30.Good faith efforts to confirm the status of both the mp30 and the patient were conducted, but these attempts were unsuccessful.If additional information is later obtained, this complaint will be reopened.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: MP30 INTELLIVUE PATIENT MONITOR
• Type of Device: COMPACT PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 10742881
• MDR Text Key: 213384444
• Report Number: 9610816-2020-00393
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K030038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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: M8002A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 70