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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY PC-1000; PC-1000/LASER 1000
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PANORAMIC CORPORATION PANORAMIC X-RAY PC-1000; PC-1000/LASER 1000 Back to Search Results
Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)
Patient Problem No Patient Involvement (2645)
Event Date 12/28/2016
Event Type  malfunction  
Event Description
A recall for this issue was initiated on 23-apr-2015.The office's technician (b)(4) called us and let us know the machine came down suddenly.During the investigation it was discovered that the machine was being lowered for the x-ray when the machine came down unexpectedly.No patients or staff members were injured.
 
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Brand Name
PANORAMIC X-RAY PC-1000
Type of Device
PC-1000/LASER 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 Key6277771
MDR Text Key65770814
Report Number1832462-2017-00004
Device Sequence Number1
Product Code EHD
UDI-Device Identifier00862309000316
UDI-Public00862309000316
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 company representative,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Remedial Action Repair
Type of Report Initial
Report Date 01/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dental Hygienist
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2002
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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