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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 NamePANORAMIC X-RAY PC-1000
Type of DevicePC-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
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
0 Patients were 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 the Report Sent to FDA?
Event Location No Information
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

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