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

Model Number M8007A

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Cyanosis (1798); Hypoxia (1918); Low Oxygen Saturation (2477)

Event Date 05/03/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported "no audible desat alarm." the device was used for monitoring at the time of the alleged malfunction.The customer observed the patient as 'blue' in color and desat level was at 27.The patient was coded and was provided oxygen, the patient was revived and moved to another room.The patient is stated to be stable.

Manufacturer Narrative

The reported problem was investigated via remote support who established that the customer observed a spo2 desat alarm on (b)(6) 2017 11:15 ¿ 11:20am, however claimed to not hear the audible alarm.The customer wants to know if the alarm was paused or if this is an issue with the monitor.The biomed was able to test high/low limits of sp02 to generate audible alarms.Monitor responded and alarmed in all cases using separate simulators.The biomed stated that the alarm was paused when he got to the room.The device was not returned to the factory for evaluation as the field service engineer (fse) was already onsite, but could not provide the logs of the timeframe in question,although these were requested numerous times.Thus this case could not be investigated any further.With the available information, philips has not been able to establish exactly what happened at the time of the reported event, and therefore it was not possible to establish a clear cause.Therefore the customer's question regarding a paused alarm or a potential malfunction of the monitor could not be answered with the limited information provided.The fse stated the monitor in question was placed back in service and has been working without issue after the incident.Stable.The biomed could not reproduce the reported problem and found the device to be operating correctly.It was impossible to determine the root cause for the issue due to the lack of the monitor and alarm logs for the time of the incident.The product remains at the customer site.It was impossible to determine the root cause for the issue due to the lack of the relevant monitor and alarm logs.However, a malfunction of the device cannot be ruled out.Additionally, 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.The fse stated that the hospital will not provide patient information like sex, age and weight.

• 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: wendy chadbourne ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6597379
• MDR Text Key: 76135419
• Report Number: 9610816-2017-00163
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 05/30/2017
• Supplement Dates Manufacturer Received: 05/04/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2011
• 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): Life Threatening