CADD
Received Dec 27, 2024 · Event occurred Dec 1, 2024
Report 3012307300-2024-15540 · MDR key 21028543
Device
Generic name
Accessories, Pump, Infusion
Manufacturer
Smiths Medical Asd, Inc.Catalog number
21-2131-25
Lot number
13628719
Product problems
- Wireless Communication Problem
- Wireless Communication Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE HAD WIRELESS MODULE INTERMITTENT SIGNAL. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.
Additional Manufacturer Narrative
WHILE PERFORMING A REVIEW OF THE FILE IT WAS DETERMINED THAT IT WAS A DUPLICATE OF AN EXISTING COMPLAINT RECORD. PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH FILE MRN 3012307300-2024-15540-00.