MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX550 PATIENT MONITOR

Model Number 866066

Device Problem Device Fell (4014)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  Injury  

Event Description

It was reported that while the registered nurse (rn) was prepping room (704) for patient arrival, the arm and mounting plate of the monitor came out of the wall in one piece.Rn attempted to catch the monitor / unit (monitor, arm, mounting plate) as it came out of the wall.Staff came to assist rn and lower the unit to the ground.No patient was in the room at the time, no patient harm.Rn complains of left shoulder and elbow pain from catching the monitor.The device was being prepared for patient arrival at the time of the alleged malfunction.

Event Description

In this case, it was reported that "while registered nurse (rn) was prepping room (704) for patient arrival the arm and mounting plate the monitor was mounted on came out of the wall in one piece.Rn attempted to catch the monitor/unit (monitor, arm, mounting plate) as it came out of the wall.Staff came to assist rn and lower the unit to the ground.The device was being prepared for patient arrival at the time of the alleged malfunction.There was no adverse event to the patient.It was reported that the rn complains of left shoulder and elbow pain from catching the monitor.

Manufacturer Narrative

It was reported that the arm and mounting plate came out of the wall in one piece.Philips clinical specialist stated that the reported event happened while he and philips field service engineer were on-site installing new monitors.Philips clinical specialist and philips field service engineer proceeded to further investigate the reported issue engaged the customer¿s biomed leadership.Biomed leadership then engaged customer facilities, who installed the wall mount to review.The room was subsequently closed for patient use.The customer then inspected wall mounts previously installed during the project and made necessary changes.Philips clinical specialist stated that the rn held onto the arm as it came out of the wall and fell.Rn complained of shoulder pain after this event.Rn went to occupation health onsite and was back to work the next day.No additional information was shared with the philips clinical specialist regarding the treatment/medication provided to the rn.There was no patient involvement.The customer then inspected wall mounts previously installed during the project and made necessary changes.The device worked as intended and there was no malfunction of the device.The product remains at the customer site.

• Brand Name: INTELLIVUE MX550 PATIENT MONITOR
• Type of Device: INTELLIVUE MX550 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• MDR Report Key: 11723116
• MDR Text Key: 248131864
• Report Number: 9610816-2021-10090
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038783
• UDI-Public: 00884838038783
• Combination Product (y/n): N
• PMA/PMN Number: K131872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup

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: No Information
• Device Model Number: 866066
• Device Catalogue Number: 866066
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/29/2021
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other