MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH PROXIDIAGNOST N90; SYSTEM, X-RAY, STATIONARY

Model Number 706100

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.

Event Description

The customer complained that the ceiling suspension for monitor rolled out of rails.No harm to the patient has been reported to philips.

Manufacturer Narrative

Int.Ref.(b)(4).The proxidiagnost is a nearby radiography system.As an option, monitors are installed in the examination room on a so named monitor ceiling carriage running in ceiling rails.The user can manually move the monitor ceiling carriage within a range that is restricted by end stops mounted inside the ceiling rails.The system can also include an optional over table tube which is mounted also on ceiling rails.The monitor ceiling carriage can be mounted on separate or on the same rail as the over table tube.At this site the monitor ceiling carriage used its own ceiling rails.Philips field service engineer investigated on site.He found out that two of four rolls of the monitor ceiling carriage had rolled over the end of the ceiling rails, but the monitor ceiling carriage could not fall out, because the transverse rails from the over table tube prevented from falling down.The field service engineer also reported that the missing stopper on the ceiling rails for monitor ceiling carriage were not recognized because this ceiling rails ends at the transverse rails of the over table tube and just was not noticed during installation.The event was originally reported to the authorities as not enough information was available to make a definite reportability decision.Since that time, additional information was received which revealed that the event does not meet the criteria for reporting.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.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 Description

The customer complained that the ceiling suspension for monitor rolled out of rails.No harm to the patient has been reported to philips.

• Brand Name: PROXIDIAGNOST N90
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstr. 24; hamburg 22335 ; GM 22335
• MDR Report Key: 9191639
• MDR Text Key: 181521649
• Report Number: 3003768251-2019-00019
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K173433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

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: 706100
• Device Catalogue Number: 706100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1