MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS VS4 VITAL SIGNS MONITOR; PATIENT MONITOR

Model Number	863283
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
Event or Problem Description
The customer reported the monitor fell from the holder.The customer confirmed that the device was not connected to a patient.
Additional Manufacturer Narrative
H10: the plastic holder, at the top of the suresigns roll stand, was replaced to resolve the issue.Vs4 and suresigns roll stand are now working as planned.The device remains at the customer site, and no subsequent calls have been logged for this device/issue.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: VS4 VITAL SIGNS MONITOR
• Common Device Name: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10560554
• Report Number: 1218950-2020-05544
• Device Sequence Number: 11503568
• Product Code: DXN
• UDI-Device Identifier: 00884838028890
• UDI-Public: (01)00884838028890
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K120132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 863283
• Device Catalogue Number: 863283
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1