MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE X3; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number 867030

Device Problems Improper or Incorrect Procedure or Method (2017); Device Fell (4014)

Patient Problem Hematoma (1884)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

On (b)(6) 2020 around 03:00am, a confused patient tore at the cables and the intellivue x3 device fell on his head.A serious injury was reported.Device fell on (b)(6) year old male patient's head.Large hematoma at the upper jaw and left half of the face and there was no fracture.

Manufacturer Narrative

H3 and h6: the field service engineer (fse) went for onsite service and further investigation of the reported incident.The visible and functional check of locking mechanism and release bottom was done.No physical damages are visible.The intellivue x3 was securely seated in.During the investigation of the intellivue x3 the fse found that the device works as intended, no malfunction was present.The provided information and the evaluation results do not indicate that a malfunction of the device occurred.This is considered a patients issue.The product remains at the customer site.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: INTELLIVUE X3
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 10436002
• MDR Text Key: 203812487
• Report Number: 9610816-2020-00288
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838082588
• UDI-Public: (01)00884838082588
• Combination Product (y/n): N
• PMA/PMN Number: K171801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

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: Health Professional
• Device Model Number: 867030
• Device Catalogue Number: 867030
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR
• Patient Weight: 75