Catalog Number 5100015272 |
Device Problem
Disassembly (1168)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 09/02/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).One event was reported for this quarter.One device was received for evaluation.One device evaluation is in progress.There were no remedial actions taken.This device is not labeled for single-use.
|
|
Event Description
|
This report summarizes 1 malfunction event in which the device disassembled.One reported event had no patient involvement; no patient impact.
|
|
Event Description
|
This report summarizes 1 malfunction event in which the device disassembled.1 reported event had no patient involvement; no patient impact.
|
|
Manufacturer Narrative
|
This mdr report is part of the malfunction summary reporting program, exemption number e2015055. supplemental rationale 1 previously reported event is included in this follow-up record.Product return status 1 device was received for evaluation.Evaluation status 1 event was not confirmed during testing; the device was found to be within specifications.Additional information 1 device is not labeled for single-use.1 device was not reprocessed and reused.
|
|
Search Alerts/Recalls
|