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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: YOUNG INNOVATIONS PANORAMIC X-RAY MODEL PC-1000

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YOUNG INNOVATIONS PANORAMIC X-RAY MODEL PC-1000 Back to Search Results
Model Number 800724-1
Device Problems Mechanical Problem (1384); Device Operational Issue (2914); Unintended Movement (3026)
Patient Problem Abrasion (1689)
Event Date 05/02/2018
Event Type  malfunction  
Manufacturer Narrative
The dentist emailed and stated that the screw motor assembly failed. The overhead chassis lightly made contact with a girl. The dentist applied antibiotic and a band-aid. The mother took the girl to the physician to make sure she was alright. The physician reapplied antibiotic and a band-aid. The girl was not hospitalized. The dentist purchased a screw motor and had it shipped to his office. He is having his own technician replace the motor since there are no panoramic certified technicians in (b)(4).
 
Event Description
Dr. (b)(6) notified us be email on (b)(6) 2018 that three weeks prior (1st week of (b)(6)approximately), a patient was entering the unit and the screw motor assembly failed. The overhead chassis made contact with the patient. On (b)(6) 2018, the doctor gave us the serial number and other required information for this incident so we could investigate and create a case. The screw motor is stuck now and will not go up. The patient was scraped on the cheek and shoulder. The patient was treated with antibiotic and a band-aid on the cheek.
 
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Brand NamePANORAMIC X-RAY MODEL PC-1000
Type of DevicePC-1000
Manufacturer (Section D)
YOUNG INNOVATIONS
4321 goshen rd.
fort wayne IN 46818
Manufacturer (Section G)
YOUNG INNOVATIONS
4321 goshen rd.
fort wayne IN 46818
Manufacturer Contact
adrienne demland
4321 goshen rd.
fort wayne, IN 46818
8006542027
MDR Report Key7598026
MDR Text Key111058098
Report Number1832462-2018-00003
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
PMA/PMN Number
K870236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Remedial Action Repair
Type of Report Initial
Report Date 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Model Number800724-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/1998
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/13/2018 Patient Sequence Number: 1
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