ACROBAT-I STABILIZER
Report
- Report Number
- 2242352-2018-00269
- Event Type
- Malfunction
- Date Received
- March 23, 2018
- Date of Event
- February 9, 2018
- Report Date
- March 23, 2018
- Manufacturer
- MAQUET CV
- Product Code
- MWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
(B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.
(B)(4).
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER CUSTOMER GRADUALLY INCREASED THE VACUUM PRESSURE TO 30KPA, AND THEN TO 40KPA, BUT IT WAS UNABLE TO SECURE THE DEVICE. OPENED ANOTHER OM-10000, REPLACED THE TUBE, AND INCREASED THE PRESSURE. THEN IT WAS ABLE TO SECURE THE DEVICE. THE GGJ SALES PERSON CHECKED THE DEVICE CONNECTION AND NO PROBLEMS WERE FOUND. THE TUBE SEEMS TO HAVE A PROBLEM. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER CUSTOMER GRADUALLY INCREASED THE VACUUM PRESSURE TO 30KPA, AND THEN TO 40KPA, BUT IT WAS UNABLE TO SECURE THE DEVICE. OPENED ANOTHER OM-10000, REPLACED THE TUBE, AND INCREASED THE PRESSURE. THEN IT WAS ABLE TO SECURE THE DEVICE. THE GGJ SALES PERSON CHECKED THE DEVICE CONNECTION AND NO PROBLEMS WERE FOUND. THE TUBE SEEMS TO HAVE A PROBLEM. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210881 | ACROBAT-I STABILIZER | STABILIZER,HEART | MWS | MAQUET CV | 25135319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |