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

Model Number 709030

Device Problems Poor Quality Image (1408); Device Handling Problem (3265); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Ref.Id: (b)(4).The combi diagnost r90 is a digital motorized remote controlled x-ray system used for radiographic and fluoroscopic imaging.Philips field service engineer (fse) went on site.A replacement of the affected detector is necessary.No details were provided about the circumstances when the detector fell down.As the customer did not make other claims, it is concluded that the detector was dropped by accident (use error).The affected detector was replaced.After replacement, the system meets manufacturers specification and is returned to use.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.

Event Description

The customer reported that the portable detector fell and has now artefacts in the image.A dropped detector can lead in worst case to a fracture in the foot.No injury reported.

• Brand Name: COMBIDIAGNOST R90
• Type of Device: TABLE, RADIOLOGIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer Contact: dusty leppert ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 17480266
• MDR Text Key: 321238780
• Report Number: 3003768251-2023-00044
• Device Sequence Number: 1
• Product Code: JAA
• UDI-Device Identifier: 00884838076747
• UDI-Public: 00884838076747
• Combination Product (y/n): N
• Reporter Country Code: LU
• PMA/PMN Number: K163210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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