MAUDE Adverse Event Report: PHILIPS MEDICAL / PHILIPS NORTH AMERICA LLC PHILLIPS MEDICAL B/P TRANSPORT MODULE; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number M3002A

Device Problems Break (1069); Crack (1135); Detachment of Device or Device Component (2907)

Patient Problems Bradycardia (1751); Death (1802); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Irregular Pulse (2469)

Event Date 07/21/2020

Event Type  Death  

Event Description

Patient was admitted to icu due to grad 5 subarachnoid hemorrhage.Ventriculostomy drain place emergent and throughout the day had high/ abnormal blood pressures with very narrow pulse pressures.Patient was an ich/sdh and cardene gtt was being titrated according to cuff bps.Around 1400 patient went brady/asystole coded and passed away shortly after.That same night a new patient was admitted into the same room and the same equipment was being used (phillips monitor/bp cable).Patient was hypotensive in the ed and had levophed running.Upon arrival to 4n32 the patients bp was 245/208 and she was not moving at all, rechecked multiple times on multiple extremities with very abnormal bps with narrow pulse pressures.Could never get what looked like an accurate bp so rn got a dinamap and checked it using the same bp cord.Dinamap showed bp to be 66/52.A new phillips x2 box was placed into 4n32 and checked bp with same cord as before.Bp was consistently low in 60s/40s which appeared to be more consistent with what was being charted in the ed (hypotension).To confirm that the x2 monitor was malfunctioning we checked a bp using the same cord as all the other times on a healthy rn and the bp read 144/122.Checked her actual bp which was 116/70.Equipment was removed from service and biomed was called regarding malfunctioning equipment and a stat request was made to have the device looked at.Biomed's evaluation: i went to 4n icu and picked up an intellivue x2, model number m3002a with serial number (b)(4) and control number 04138 from the nurse's station.I noticed that this device had damage to the top of the end cap and i could hear something rolling around inside the unit.I brought it to the biomed department and used a patient simulator to test it.Test equipment control numbers used are 53714 and 53715.Here are the findings: simulator was set for 60/30 for non invasive blood pressure and this device gave a reading of 187/139 the first time and 172/138 the second time.Simulator was then set for 120/80 and the readings were 166/140 and 173/136.Simulator was set at 150/100 and this device gave readings of 173/136 and 173/140.Simulator was then set at 200/150 and this device gave readings of 170/118 and 191/161.I then tested ecg and set the simulator at 60 bpm and the device gave me a reading of 60 bpm.The simulator was then set for 80 bpm and the device read 80 bpm.The simulator was set to 120 bpm and the device gave a reading of 120 bpm.Spo2 was then tested and the simulator was set at 95%, 98% and 100%.The intellivue x2 gave readings of 95%, 98%, and 100%.Respiration was then tested at 10 brpm, 20 brpm and 30 brpm.The x2 gave readings of 10 brpm, 20 brpm and 30 brpm.Invasive blood pressure was tested at 120/80 and 150/100 and this device gave readings of 120/80 and 150/100.I then opened the front case of the device and found a screw rolling around inside it and the snap that secures the ribbon cable to the screen was cracked and fell off.I tried to reinsert the screw in the location it came from but the hole was stripped out and it would not retain the screw to secure the internal circuit board.Fda safety report id #: (b)(4).

• Brand Name: PHILLIPS MEDICAL B/P TRANSPORT MODULE
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDICAL / PHILIPS NORTH AMERICA LLC
• MDR Report Key: 10361498
• MDR Text Key: 201766526
• Report Number: MW5095852
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3002A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR