MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH COMBIDIAGNOST R90; TABLE, RADIOLOGIC

Model Number 709030

Device Problem Device Fell (4014)

Patient Problem No Patient Involvement (2645)

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 footrest fell when the table was placed vertically.In a worst case, a patient can fall down.There was no patient on the table at the time of the incident.No injury occurred.

Manufacturer Narrative

(b)(4).The combidiagnost r90 is a remote controlled motorized digital x ray system used for radiographic and fluoroscopic imaging, with a digital detector as image receiver.A foot rest is provided to help support the patient during table tilting.Philips field service engineer investigated on site and found the footrest was severely damaged at the right side.The footrest was send back to the legal manufacture for analysis.The locking mechanism at the left side (without damage) was fully functional.The instructions for use clearly warn the operator (danger! mark) that upon footrest mounting the correct locking must be checked and it is described how this is to be done.This potentially leads to the cause of the falling footrest: the operator did not check the correct locking before tilting the table and the footrest fell.The falling footrest was a result of an use error.Philips field service engineer exchanged the damaged footrest and the system works as specified again.Risk estimation revealed acceptable risk per risk benefit analysis, because actually, there is no feasible technical solution for this kind of ¿use error¿.This issue is further monitored and trended.Correction: h6 result , conclusion and report source.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: COMBIDIAGNOST R90
• Type of Device: TABLE, RADIOLOGIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstr. 24; hamburg 22335 ; GM 22335
• MDR Report Key: 8491119
• MDR Text Key: 141332440
• Report Number: 3003768251-2019-00004
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K163210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

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: 709030
• Device Catalogue Number: 709030
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1