Model Number MODEL 250 |
Device Problems
Charging Problem (2892); Communication or Transmission Problem (2896)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/22/2014 |
Event Type
malfunction
|
Event Description
|
It was reported that the serial cable for the handheld device was causing communication and charging issues.The wand battery was replaced and the wand was confirmed to be functioning properly when connected to another handheld device.The handheld device was returned to the manufacturer where analysis is currently underway.
|
|
Event Description
|
Analysis of the handheld was completed on (b)(4) 2014.During the analysis it was identified that the handheld would not power on using the ac adapter.The cause for the anomaly is associated with damaged leads associated with the handheld sync connector.Because of the damage, the handheld was unable to receive power from the ac adapter.The cause for the damage to the connector leads and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle.No other anomalies were identified.Analysis of the flashcard was completed on (b)(4) 2014.No anomalies associated with flashcard software or databases were identified during the flashcard analysis.The flashcard and software performed according to functional specifications.
|
|
Manufacturer Narrative
|
Device failure occurred, but did not cause or contribute to a death or serious injury.
|
|
Search Alerts/Recalls
|