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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY MODEL PC-1000
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PANORAMIC CORPORATION PANORAMIC X-RAY MODEL PC-1000 Back to Search Results
Model Number 800724-1
Device Problem Migration or Expulsion of Device (1395)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2013
Event Type  malfunction  
Event Description
A recall for this issue was initiated on 23-apr-2015.Doctor called in to report the machine will go down but not up and sometimes during exposures everything will stop.When the service technician arrived there was additional damage to support a machine fall.The service technician repaired the machine.No patient involvement.
 
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Brand Name
PANORAMIC X-RAY MODEL 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 Key6063984
MDR Text Key58713701
Report Number1832462-2016-00016
Device Sequence Number1
Product Code EHD
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 Dentist
Remedial Action Repair
Type of Report Initial
Report Date 10/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2016
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? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/06/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/1999
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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