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

Model Number 709030

Device Problems Device Handling Problem (3265); Device Fell (4014)

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

Event Type  malfunction  

Event Description

The customer reported that the portable detector failed the gain calibration during the quarterly check.A dropped detector can lead in worst case to a fracture in the foot.No injury reported.

Manufacturer Narrative

Ref.Id: (b)(4).The local field service engineer (fse) went on site and found shocks recorded on the affected detector.The detector needs to be replaced.He returned to the site and installed and calibrated a new detector.Finally, the system meets the specification for the performed service and is returned to use.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).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.

• 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: 19191028
• MDR Text Key: 341139243
• Report Number: 3003768251-2024-00023
• Device Sequence Number: 1
• Product Code: JAA
• UDI-Device Identifier: 00884838076747
• UDI-Public: 00884838076747
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• 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: 03/29/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• 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