MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX700 PATIENT MONITOR

Model Number 865241

Device Problem Self-Activation or Keying (1557)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that on (b)(6) 2018 between 9:00-10:00, the red alarm has self-acknowledged, and then has not been acoustically reproduced.It was stated that the spo2 dropped to 52 and the patient was immediately treated with a ventilator-bag; the patient stabilized.

Manufacturer Narrative

No product malfunction was found.Alarm audit logs were submitted to philips by the customer, and were reviewed by product support engineering (pse).The logs showed the device had provided alarms between 9:00am and 10:00am.According to the above extracts from the logs, at 9:12:45, a red desat alarm was generated at the central station (pic ix).The log indicated that the red alarm was accompanied by audio alarming.The logs further show that alarm silencing actions were taken by someone at the pic less than two minutes after those alarms were generated; that would imply that the pic was generating an audio alarm and someone choose to silence it.Yellow alarms were seen, after the silencing, including abp and etco2 alarms, up to 9:18:44, which was the time of the reported vtachy alarm.Regarding the spo2, this was a persistent condition that was confirmed via the logs, event/alarm bar, and the vitals data which shows the o2 sat was still 57 at 9:20.The customer was informed of the investigation findings.No parts were ordered and no repair was warranted.The device remains at the customer site.No further investigation 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 MX700 PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 7956803
• MDR Text Key: 123431339
• Report Number: 9610816-2018-00265
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K110622
• 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: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865241
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention