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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN PROPAQ ENCORE 206/EL

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WELCH ALLYN PROPAQ ENCORE 206/EL Back to Search Results
Model Number ENCORE 206/EL
Device Problems Device Alarm System (1012); Loss of Power (1475); Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/12/2015
Event Type  malfunction  
Manufacturer Narrative
Welch allyn is reporting this in an abundance of caution for a potential unexpected device shutdown.The unit has not been returned to welch allyn at this time.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer stated that the device would shut down without alarms or alerts when attempting a print function snapshot.
 
Manufacturer Narrative
The device was not returned to welch allyn for evaluation.Troubleshooting with the customer confirmed that the device had an aged battery.The battery was replaced and the device functioned as intended.Welch allyn will be communicating with its consignees to reaffirm following the directions for use for proper battery care.
 
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Brand Name
PROPAQ ENCORE 206/EL
Type of Device
PROPAQ ENCORE 206/EL
Manufacturer (Section D)
WELCH ALLYN
4341 state street road
p.o. box 220
skaneateles falls NY 13153 0220
Manufacturer (Section G)
WELCH ALLYN
4341 state street road
p.o. box 220
skaneateles falls NY 13153 0220
Manufacturer Contact
amy forbes
4341 state street road
p.o. box 220
skaneateles falls, NY 13153-0220
3156852597
MDR Report Key5065244
MDR Text Key25934280
Report Number1316463-2015-00041
Device Sequence Number1
Product Code DRT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K910882
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Biomedical Engineer
Device Model NumberENCORE 206/EL
Device Catalogue NumberENCORE 206/EL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/12/2015
Initial Date FDA Received09/09/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2008
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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