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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY PC-1000
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PANORAMIC CORPORATION PANORAMIC X-RAY PC-1000 Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/09/2017
Event Type  Injury  
Event Description
On (b)(6) 2017, (b)(6) called in and said that the machine was drifting down with a patient positioned in the machine.The patient was injured but the machine did drift away from where they were positioned and the head support may have made contact with the top of the patient's head.No patient information available.
 
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Brand Name
PANORAMIC X-RAY PC-1000
Type of Device
PC-1000
Manufacturer (Section D)
PANORAMIC CORPORATION
4321 goshen road
fort wayne IN 46818
Manufacturer (Section G)
PANORAMIC CORPORATION
4321 goshen road
fort wayne IN 46818
Manufacturer Contact
tammy shiffler
4321 goshen road
fort wayne, IN 46818
8006542027
MDR Report Key6418106
MDR Text Key70371160
Report Number1832462-2017-00005
Device Sequence Number1
Product Code EHD
UDI-Device Identifier00862309000309
UDI-Public00862309000309
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K870236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Dental Assistant
Remedial Action Repair
Type of Report Initial
Report Date 03/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Dental Assistant
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/29/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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