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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PELTON & CRANE DELTA Q AUTOCLAVE

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PELTON & CRANE DELTA Q AUTOCLAVE Back to Search Results
Model Number AF
Device Problem Component Falling (1105)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The sterilizer was returned to pelton & crane on 3/28/2018. Our evaluation indicates there was severe damage to the front of the sterilizer indicating the sterilizer had fallen off the table it was sitting on. Moreover, the door handle bar assembly was bent inwards indicating a direct impact to the front of the sterilizer when the sterilizer fell to the floor. The chamber and door locking mechanism was evaluated and there was no structural damage to the chamber, door, hindges, and latching pins. Pelton & crane has left multiple messages with the doctors office for dr. (b)(6) to call us back to further discuss the complaint he e-mailed to us as well as to determine the date of the event but the dr. Has not returned our calls. As a result, the sterilizer appears to have been abused as it was not properly positioned on the table for use. Also the sterilizer was not being properly maintained over time as the sterilizer chamber, trays, and filters are very dirty and shows lack of proper maintenance.

 
Event Description

Pelton & crane received a complaint via e-mail stating a delta q 10" sterilizer door came open during a sterilizing cycle causing a loud noise. The staff went into the room as saw the sterilizer, trays, and the various instruments they were sterilizing on the floor with the sterilizer door open. No one was in the room when the event took place. There were no injuries reported.

 
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Brand NameDELTA Q
Type of DeviceAUTOCLAVE
Manufacturer (Section D)
PELTON & CRANE
11727 fruehauf drive
charlotte NC 28273
Manufacturer (Section G)
PELTON & CRANE
11727 fruehauf drive
charlotte NC 28273
Manufacturer Contact
frank ray
11727 fruehauf drive
charlotte, NC 28273
MDR Report Key7429038
MDR Text Key105776752
Report Number1017522-2018-00011
Device Sequence Number1
Product Code FLE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK945117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation DENTIST
Type of Report Initial
Report Date 03/16/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator DENTAL ASSISTANT
Device MODEL NumberAF
Device Catalogue NumberAF
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/28/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/16/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/28/2008
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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