MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE FMS-4

Model Number	865243
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the arm holding the patient monitor, which is connected to the wall, when moving the monitor down, there is no soft landing.The resistance on the arm is missing and one of the nurses injured her shoulder.Some arms seem ok but some of them are also having this same problem in the icu.It is unknown if the device was in clinical use at the time of the event.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.Reporting address state: (b)(6).
Additional Manufacturer Narrative
Additional information was provided that the nurse had a minor injury of shoulder pain; the nurse recovered.The response also indicated that it was unknown who installed the mount at the customer site.Based on the information available, the cause of the reported problem was the screw and nut that's connected to the black lever was loose.No additional diagnostic/functional testing was performed.The reported problem was confirmed.The customer was advised to tighten the screw and nut that's connected to the black lever.The customer confirmed that this tightening resolved the fault.The investigation concludes that no further action is required at this time.

• Brand Name: INTELLIVUE FMS-4
• Common Device Name: INTELLIVUE FMS-4
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 18861471
• Report Number: 9610816-2024-00137
• Device Sequence Number: 3325913
• Product Code: DSI
• UDI-Device Identifier: 00884838029279
• UDI-Public: 00884838029279
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 865243
• Device Catalogue Number: 865243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female