MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number 712050

Device Problem Device Fell (4014)

Patient Problems Head Injury (1879); Ambulation Difficulties (2544)

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 reported that the patient support for stitching tipped over on the female patient when she lost balance and stepped forward.The patient support for stitching hit the patient on the head which resulted in a bump.No serious injury occurred.

Manufacturer Narrative

Int.Ref.(b)(4).The patient support (for stitching) is an accessory that enables the examination of full leg or full spine, with the patient standing upright.For ease of use, the patient support has wheels and a folding footboard.There are grips for supporting the patient in the correct position.The patient support is designed according to (b)(4), to be safe against tilting over.The customer reported that the patient has been stood with her back to the back of the patient support, facing out towards the x ray tube.She has leant onto the grips.When the patient fainted, she lost balance, fell forward and pulled the patient support with her.The system has been checked for correct functioning.All fastenings, brakes, grab rails and arm supports found to be in good condition.Device is within manufacturer¿s specification.The event was originally reported to the authorities as not enough information was available to make a definite reportability decision.Since that time, additional information was received which revealed that the event does not meet the criteria for 21 cfr 803.Conclusion: 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: DIGITALDIAGNOST
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstr. 24; hamburg 22335 ; GM 22335
• MDR Report Key: 7868214
• MDR Text Key: 120257923
• Report Number: 3003768251-2018-00006
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• PMA/PMN Number: K982795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

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: 712050
• Device Catalogue Number: 712050
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 92