MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX; CENTRAL MONITORING STATION

Model Number 866389

Device Problem Device Fell (4014)

Patient Problem Ecchymosis (1818)

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that the unit fell and hit an employee causing bruising.The bruising on the employee's head was around a quarter size and on her shoulder.They were released from the emergency department after evaluation and back at work the next day.There was no report of a serious injury.Additional information was received that a philips representative installed two philips displays on the stand which is located on a desk and is approximately 3 feet tall [above desk height.] the philips technical consultant (tc) verified that the stand is stable and tried moving/shaking the setup.The stand would not move unless great force was applied.It is unclear how moving the keyboard caused the stand to fall over.The cables are placed to the side, there was no entanglement of cords that may have contributed to the event.The tc stated the philips equipment did not fall, the quad mount display stand, which is a third-party device, fell over.

Manufacturer Narrative

Additional details provided by the philips technical consultant (tc) regarding the incident and the monitor stand setup confirms that the cisco ws-c2960x-24ps-l is not the alleged equipment that fell.It was the quad mount display stand that fell, (a third-party item) supplied by philips as part of the value added service (vas) for this customer installation.The tc indicated that the displays which were attached to the stand must have caused the injury as the stand itself is just a pole.The complaint was initially logged on cisco ws-c2960x-24ps-l product, however the record registers patient information center ix (pic ix) as product due to reportability requirement, but the pic ix pc was not involved in the incident.The cause of the reported problem was a fall of the quad mount display stand.The engineer provided his analysis findings.There is indication that the displays must have caused the injury as the stand itself is just a pole.Philips verified that the area was free of any entanglement of cords or cables that would contribute to the event.Tests revealed the stand to be stable and it would not move unless great force was applied; thus, it is unclear how moving the keyboard caused the stand to fall over.If additional information is received the complaint file will be reopened.A3 gender: updated to female.D4 serial number: updated to (b)(6).D4 product udi/device identifier: updated to (b)(4).H4 device manufacture date: updated to 04/13/2022.H evaluation method code grid: added c91896.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: CENTRAL MONITORING STATION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18104531
• MDR Text Key: 327772974
• Report Number: 1218950-2023-00855
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 12/31/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• 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 Sex: Female