MAUDE Adverse Event Report: PROTEC GMBH & CO. KG PROGNOST XS; BASIC DIAGNOSTIC X-RAY TABLE, UNPOWERED

Model Number 7034-0-0000

Device Problem Solder Joint Fracture (2324)

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

Event Date 08/11/2021

Event Type  malfunction  

Event Description

A patient fell from the mobile x-ray system table (type prognost xs) onto the bucky holder of the x-ray u-arm system used underneath.This is because the table top tilted when the patient sat on the table to take off his shoes.The table top bent towards the bucky holder underneath and the table stopped.Due to the low height of the fall, the patient was not injured in the incident and was able to leave the examination room independently and without any impairments.Third persons were also not injured.Besides the damage to the table, only damage to the x-ray u-arm system was reported to the manufacturer.After informing the manufacturer, the x-ray system table was immediately ordered to be taken out of service.This was implemented by the health facility; the affected table was replaced on (b)(6) 2021.

Manufacturer Narrative

Field safety corrective action: retrofitting the prognost xs in the field with supplementary support plates to reinforce the stressed weld seams.

• Brand Name: PROGNOST XS
• Type of Device: BASIC DIAGNOSTIC X-RAY TABLE, UNPOWERED
• Manufacturer (Section D): PROTEC GMBH & CO. KG; in den dorfwiesen 14; oberstenfeld, baden-wuerttemberg 71720 ; GM 71720
• Manufacturer (Section G): PROTEC GMBH & CO. KG; in den dorfwiesen 14; oberstenfeld, baden-wuerttemberg 71720 ; GM 71720
• Manufacturer Contact: frank baisch ; in den dorfwiesen 14; oberstenfeld, baden-wuerttemberg 71720 ; GM 71720
• MDR Report Key: 12778577
• MDR Text Key: 285964297
• Report Number: 3004127954-2021-00001
• Device Sequence Number: 1
• Product Code: KXJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/09/2021

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: 7034-0-0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• 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
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White