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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN SCALETRONIX / WELCH ALLYN PEDIATRIC SCALE PEDIATRIC / INFANT SCALE

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WELCH ALLYN SCALETRONIX / WELCH ALLYN PEDIATRIC SCALE PEDIATRIC / INFANT SCALE Back to Search Results
Model Number 4802
Device Problems No Display/Image (1183); Electrical /Electronic Property Problem (1198); Loose or Intermittent Connection (1371); Device Inoperable (1663)
Patient Problems Non specific EKG/ECG Changes (1817); Brain Injury (2219)
Event Date 10/10/2015
Event Type  Injury  
Manufacturer Narrative
A review of welch allyn post market surveillance data from (b)(6) 2015 to the present shows no previous complaint for this incident. The device has not been returned for investigation due to the pending litigation. If welch allyn becomes aware of additional information a follow up report will be filed. This mdr is filed in an abundance of caution due to the serious injury.
 
Event Description
Welch allyn received litigation regarding an alleged incident that occurred on (b)(6) 2015 at (b)(6) medical center in (b)(6). The complaint alleges that a nurse, received a shock from the power cord of a scale-tronix pediatric scale. The nurse, while attempting to weigh a (b)(6)-day old infant, noticed that the scale display was not functioning. The nurse returned the infant to the mother and reached to adjust the power cord of the pediatric scale when she immediately felt a shock to her right side and was thrown back approximately 12 feet, striking her head and losing consciousness. The nurse was seen in the emergency department and diagnosed with ecg abnormalities and a tbi (traumatic brain injury).
 
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Brand NameSCALETRONIX / WELCH ALLYN PEDIATRIC SCALE
Type of DevicePEDIATRIC / INFANT SCALE
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
edward o'neil
4341 state street road
skaneateles falls, NY 13153-0220
3155544055
MDR Report Key7097437
MDR Text Key94194807
Report Number1316463-2017-00009
Device Sequence Number1
Product Code FRW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 11/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4802
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/07/2017 Patient Sequence Number: 1
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