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

Model Number M8007A

Device Problem Defective Alarm (1014)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/28/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the factory for evaluation as the field service engineer (fse) was already onsite and established that the incident happened in the night from (b)(6) 2018.However, the customer could not provide an exact time frame of the incident.The monitor was also tested by the local biomedical engineer and there was no trouble found with the device, he confirmed that all spo2 alarms were working as specified during testing.The fse stated that as the patient had been discharged, only limited information or logs from the bedside monitor were available.The bed label was nicu27 with equipment label nicu 27.Although the fse stated that the log files indicate the monitor continually alarmed for spo2 low alarms and desat alarms along with other notable alarms starting at around 6 pm and continuing well into the night, no further evaluation for a particular alarm was possible as the actual time of the incident was not available.The fse saw many paused and resumed alarms in the logs all throughout the night.The fse stated that based on the analysis of the alarm logs, he found no issues with the monitor, just like the local biomedical engineer who also found no issues with the monitor during testing.The fse shared his findings from the log files with the customer.There was no trouble found with the device, however, a malfunction cannot be ruled out.It is also unknown if the device worked as intended as the exact time frame of the occurrence was not made available.However, the log files indicate that there were multiple alarms correctly triggered in the night the incident occurred, many of these alarms were paused by user interaction.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.

Event Description

The customer reported that a "low spo2 did not alarm".This happened at night on (b)(6) 2018.The device was used for monitoring at the time of the alleged malfunction.The involved patient is a male neonate, exact age is unknown, (b)(6).Oxygen delivery was required.The patient recovered and was discharged on (b)(6) 2018.

• 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: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 7470163
• MDR Text Key: 106832722
• Report Number: 9610816-2018-00104
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2007
• 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
• Patient Weight: 3