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

Model Number 712050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 09/21/2022

Event Type  Injury  

Event Description

The customer reported that a nurse hit her head on part of the ceiling suspension when transferring a patient from a stretcher.The nurse suffered a wound or laceration which required 5 stitches between the eyebrows.

Manufacturer Narrative

Ref.Id: (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.

Manufacturer Narrative

Ref.Id: (b)(4).The digitaldiagnost is a stationary x-ray system for general radiographic purposes.A philips field service engineer (fse) was dispatched to the customer hospital to investigate the problem.According to the fse the nurse was placing the patient on a stretcher into the examination room.Then she crouched down to lower the patient.When she stood up, nurse hit head hard.The nurse got five stitches between her eyebrows.The operator confirmed that the system had not malfunctioned and that the operator had injured accidentally.There is no problem with the equipment.The system meets the specification for the performed service and is returned to use.The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.

Manufacturer Narrative

Ref.Id: (b)(4).The digitaldiagnost is a stationary x-ray system for general radiographic purposes.A philips field service engineer (fse) was dispatched to the customer hospital to investigate the problem.According to the fse the nurse was placing the patient on a stretcher into the examination room.Then she crouched down to lower the patient.When she stood up, nurse hit head hard.The nurse got five stitches between her eyebrows.The operator confirmed that the system had not malfunctioned and that the operator had injured accidentally.There is no problem with the equipment.The system meets the specification for the performed service and is returned to use.Risk estimation revealed acceptable risk via risk benefit determination.The issue is further monitored and trended.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 reporting.Correction: h6 health impact code.

• Brand Name: DIGITALDIAGNOST CLASSIC
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• 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 ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15572541
• MDR Text Key: 301483770
• Report Number: 3003768251-2022-00008
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 712050
• Device Catalogue Number: 712050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 09/26/2022; 09/26/2022
• Supplement Dates FDA Received: 02/07/2023; 09/21/2023
• 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
• Patient Outcome(s): Required Intervention