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U.S. Department of Health and Human Services

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

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YOUNG INNOVATIONS PANORAMIC X-RAY MODEL PC-1000 PC-1000 / LASER 1000 Back to Search Results
Model Number 800724-3
Device Problem Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The ceph head was not clamped down correctly and a string was attached to secure the ceph head. The doctor said the reason it was not clamped down was he could not get the screws back in correctly. Panoramic sent a technician out to insure the ceph head was secured and the machine is working properly. The machine was operating properly and the ceph head was reclamped down. Picture attached. (b)(4).
 
Event Description
Dr (b)(6) mentioned the ceph head fell off the machine and near his foot. There was no injury and no medical treatment was necessary. This incident occurred about a month and half ago.
 
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Brand NamePANORAMIC X-RAY MODEL PC-1000
Type of DevicePC-1000 / LASER 1000
Manufacturer (Section D)
YOUNG INNOVATIONS
4321 goshen road
fort wayne IN 46818
Manufacturer (Section G)
YOUNG INNOVATIONS
4321 goshen road
fort wayne IN 46818
Manufacturer Contact
tammy shiffler
4321 goshen road
fort wayne, IN 46818
8006542027
MDR Report Key7823373
MDR Text Key118553405
Report Number1832462-2018-00005
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K882436
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 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number800724-3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2000
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: 08/28/2018 Patient Sequence Number: 1
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