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

Model Number M3002A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 07/15/2017

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer wants to see if data is retrievable in connection with a patient death on (b)(6) between 13:15 to 13:45 pm in room 1040 on pic icu11c2.They are questioning if they got red alarms for desaturation and apnea.The device was used for monitoring at the time of the alleged malfunction.The patient died.The involved patient was had been admitted for gastrointestinal bleeding.

Manufacturer Narrative

The reported problem was initially investigated via remote support who walked the biomed through printing the event review and wave information for this timeframe.A field service engineer (fse) was dispatched for an onsite service to gather the logs from the involved (b)(6), measurement server x2 as well as the bedside monitor mp70.The log files were forwarded to product support engineering (pse) who found that in the specified time frame there were several physiological - red alarms for desat and apnea.It was established that the monitor was alarming for potentially life threatening situations.The logs also show that several of these alarms were silenced (13:25:51 pm - silenced rm1040 - apnea; 13:26:59 pm - silenced rm1040 - apnea; 13:31:24 pm - silenced rm1040 - apnea).This supports that the monitor correctly announced the respective alarms which were then silenced.Pse stated that unfortunately there is no way in telling, where the alarms were silenced (bedside monitor or central station) because a (b)(6) classic was used, which does not indicate this fact.The product remains at the customer site.The reported issue does not indicate a malfunction of the product.The review of the log files support that the monitor correctly announced the respective alarms which were then silenced.No further investigation or action is warranted.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6787908
• MDR Text Key: 82479093
• Report Number: 9610816-2017-00243
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: M3002A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 07/18/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 116