MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

Model Number M8007A

Device Problem Device Alarm System (1012)

Patient Problem Injury (2348)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that a desat alarm did not occur at the monitor.A serious injury was reported.

Manufacturer Narrative

According to the case notes and communications with the response center engineer (rce), a technical inop did occur at the bedside, but not known for what specifically, however, at that time, it was noted that there was no spo2 value (? instead) and no trends.A review of the piic ix logs do indicate that a technical alarm occurred around the time of the expected desat alarm, however, the technical inop "no spo2 sensor" is not audited in the ix logs at this time.The field service engineer (fse) went on-site and performed testing on both the bedside and central station, and found them functioning/alarming per specifications.Based on the information that an inop tone was heard at the bedside, a "?" value was noted at the bedside, and the ix logs indicate the occurrence of a technical inop around the time of the reported incident, no device malfunction is supported and the behavior is consistent with receiving an active technical inop for spo2 which would prevent the device from alarming for a desat condition.No device malfunction occurred.

• Brand Name: MP70 INTELLIVUE PATIENT MONITOR
• 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: 6171204
• MDR Text Key: 62311144
• Report Number: 9610816-2016-00326
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention