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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PANORAMIC CORPORATION PANORAMIC X-RAY MODEL PC-1000/LASER-1000 PC-1000/PC-1000 FILM

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PANORAMIC CORPORATION PANORAMIC X-RAY MODEL PC-1000/LASER-1000 PC-1000/PC-1000 FILM Back to Search Results
Model Number 800724-1
Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)
Patient Problem No Patient Involvement (2645)
Event Date 12/08/2016
Event Type  malfunction  
Event Description
On (b)(6) 2016 a service call was received from (b)(6) secretary. She reported that the machine had fallen on (b)(6) 2016 and will not rise anymore. No patient was involvement and no injuries occurred.
 
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Brand NamePANORAMIC X-RAY MODEL PC-1000/LASER-1000
Type of DevicePC-1000/PC-1000 FILM
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 Key6230297
MDR Text Key64132982
Report Number1832462-2017-00001
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K882436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dental Assistant
Device Model Number800724-1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2001
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: 01/06/2017 Patient Sequence Number: 1
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