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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN PROTOCOL, INC. PROPAQ LT 802
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WELCH ALLYN PROTOCOL, INC. PROPAQ LT 802 Back to Search Results
Model Number TLA, MONITOR, 802LTAN
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/17/2014
Event Type  malfunction  
Event Description
The customer reported that their propaq lt powers up as unit id 8510, physical serial number on back of unit doesn't match display id.Serial number (b)(4) is already in use on another device.There was no report of any patient harm as a result of the reported event.
 
Manufacturer Narrative
We are reporting in an abundance of caution.Our evaluation of this incident is not yet complete.A follow-up report will be submit when the evaluation is complete.
 
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Brand Name
PROPAQ LT 802
Manufacturer (Section D)
WELCH ALLYN PROTOCOL, INC.
8500 s.w. creekside place
beaverton OR 97008 710
Manufacturer Contact
robert berry
8500 s.w. creekside place
beaverton, OR 97008-7107
5035307500
MDR Report Key4030892
MDR Text Key20328780
Report Number3023750-2014-00018
Device Sequence Number1
Product Code DRT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/17/2014
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? No
Device Operator Health Professional
Device Model NumberTLA, MONITOR, 802LTAN
Device Catalogue Number007-0384-00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/17/2014
Initial Date FDA Received07/16/2014
Was Device Evaluated by Manufacturer? Yes
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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