MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX550; PATIENT MONITOR

Model Number 866066

Device Problem Device Alarm System (1012)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that the intellivue mx550 patient monitor did not alarm for an asystole on (b)(6) 2019 between 03:58 and 04:07 for the patient in bed 13.The clinical staff performed cardiopulmonary resuscitation on the patient.They were able to stabilize the patient and the patient survived.

Manufacturer Narrative

H3 and h6: a philips field service engineer (fse) went to the customer site and tested the monitor.The device was found to be working as intended, all generated alarms were announced as expected and no trouble was found with the device during the testing.The fse also collected the respective logs for the reported event, which were forwarded to philips product support engineering (pse) for evaluation.During the analysis of the provided central station audit logs it was found that the date and time in question were not included in the logs.As the reported event happened some time prior to the onsite visit by the fse, the alarm review from the bedside monitor was no longer available for evaluation.Physio data provided by the fse could not be accessed by pse due to the data format and the provided ecg strips did not provide further information regarding the reported event.Based on the available details, the exact cause for the reported issue could not be established.No subsequent calls were received from the customer regarding the reported device and issue.Although the field service engineer found the monitor to be working as expected during onsite testing, the exact cause for the reported event could not be established based on the data provided and a malfunction of the monitor at the time of the event cannot be ruled out.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: INTELLIVUE MX550
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8581799
• MDR Text Key: 144097065
• Report Number: 9610816-2019-00119
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038783
• UDI-Public: (01)00884838038783
• Combination Product (y/n): N
• PMA/PMN Number: K131872
• 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: 04/16/2019

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: 866066
• Device Catalogue Number: 866066
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 05/02/2019
• Supplement Dates FDA Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention