|
Model Number PT-ASP-III-110 |
Device Problem
Failure to Power Up (1476)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/03/2023 |
Event Type
Injury
|
Event Description
|
It was reported that a psi-tec iii aspirator malfunctioned as a fuse burned out during an unspecified procedure.No information regarding patient involvement was mentioned.As a result, a service request is pending for repair of the device.Although, mentor has not received the service report or the device for repair.
|
|
Manufacturer Narrative
|
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made. as such, the investigation will be closed. if the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803. this report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date. this report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report. reason for device explant and/or reoperation: electrical fault.Manufacturer¿s reference number: (b)(4).
|
|
Manufacturer Narrative
|
On march 04, 2023, mentor was notified that there was no patient contact in regards to the device malfunction.As such, there were no patient consequences or adverse events associated with this event.Manufacturer¿s reference number: (b)(4).
|
|
Search Alerts/Recalls
|
|
|