MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX800 PATIENT MONITOR

Model Number 865240 (MX800)

Device Problem Misassembled (1398)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The faulty patient arm swivel was sent to the manufacturer gcx for further investigation, however, the investigation results were not made available.No further calls were logged from the customer regarding the reported device and issue.

Event Description

The customer reported a "failure of the gcx vhm mounting arm on (b)(6) 2018, where the down post mounts to the patient arm swivel.The vertical part of the down post adapter cuts off from the horizontal part.The broken piece hangs from the cables attached to the rack and x2 mount".The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9530846
• MDR Text Key: 177960648
• Report Number: 9610816-2019-00349
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838020733
• UDI-Public: (01)00884838020733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/15/2018

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: 865240 (MX800)
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2017
• 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