|
Model Number 72200616S |
Device Problems
Overheating of Device (1437); Mechanical Jam (2983)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that the motor drive unit had a "blade stalled" error.No case reported; therefore, there was no patient involvement.
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A complaint history review concluded this was a repeat issue.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
|
|
Manufacturer Narrative
|
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the returned device and the reported event.A visual inspection was performed on the exterior of product and no physical damage was observed.Mdu failed functional tests with blade stall error and overheating of cord.After troubleshooting, the cause of the overheating was observed to be a defective power cord assembly.It was determined that the power cord has shorted internal wiring.The complaint investigation has concluded that this unit has succumbed to physical damage to power cord.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was confirmed, and the root cause was associated with a short circuit in the power cord.Factors which can contribute to a shorted power cord include rolling a heavy cart over the cord or excessive bending of the cord.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.Several corrective actions were taken to reduce the occurrence of this failure.No further actions are required at this time.Correction in b5 & h6 (medical device problem code).
|
|
Event Description
|
It was reported that the motor drive unit had a "blade stalled" error.No case reported; therefore, there was no patient involvement.Per results of investigation the mdu failed functional tests with blade stall error and overheating of cord.
|
|
Search Alerts/Recalls
|
|
|