MalfunctionFOX
LIFECARE
Received Aug 12, 2023
Report MW5141502 · MDR key 17534601
Device
Generic name
Stand, Infusion
Manufacturer
AbbottProduct problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
STRYKER MEDICAL WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH STRYKER IS NOT THE ORIGINAL EQUIPMENT MANUFACTURER OF THE REPORTED DEVICE. THE CUSTOMER REPORTED THAT FOUR LIFE CARE IV POLES NEEDED REPAIRS. PLEASE FIND ADDITIONAL CONTACT INFORMATION BELOW. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).