MAUDE Adverse Event Report: PHILIPS HEALTHCARE (SUZHOU) CO., LTD DURADIAGNOST; SYSTEM, X-RAY, STATIONARY

Model Number 712214

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Overdose (1988)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing for this event.When the investigation is completed a follow-up will sent to the fda.

Event Description

The system had error message ¿call service- generator failed¿, patient received overdose.

Manufacturer Narrative

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.

Manufacturer Narrative

Based on our investigation, it can be concluded that no other errors was found except for the two times generator errors, system worked normally after generator automatically restarted.Based on the above investigation and logfile analysis, it was concluded that the complaint issue with black image was caused by selecting higher mas value operated by manual overridden.It was also clearly that the exposure parameters shown on ui, were selected and acknowledged by user before he/she performed x-ray exposure.According to the definition and reporting criterial of relevant radiation regulation, this complaint issue is not considered as mdr reportable incident.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: DURADIAGNOST
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS HEALTHCARE (SUZHOU) CO., LTD; no.258, zhongyuan road; suzhou industrial park; suzhou 21502 4; CH 215024
• MDR Report Key: 8878363
• MDR Text Key: 154033565
• Report Number: 3009529630-2019-00001
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K141381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2019

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: No Information
• Device Model Number: 712214
• Device Catalogue Number: 712214
• Device Lot Number: SN180054
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 07/12/2019; 07/12/2019
• Supplement Dates FDA Received: 09/24/2019; 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1