MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-07-26 for ACUITY H77 manufactured by Varian Medical Systems Uk Ltd..
[20394017]
Although, there was no reported injury in this case, the available info suggests a possible malfunction of the device. Though still under investigation, varian has determined that a mdr is appropriate as this possible malfunction, should it recur, could potentially cause serious injury. Add'l f/u to this mdr is expected upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[20413541]
The customer called due to a cbct second reconstruction problem. After performing a cbct triple scan, the reconstruction displayed images are shorter, as compared to the first reconstructed image; specifically, the bottom or lower-half portion of the second reconstructed images is missing. No error message is displayed. There was no serious injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020711-2011-00009 |
| MDR Report Key | 2231316 |
| Report Source | 01,05,06 |
| Date Received | 2011-07-26 |
| Date of Report | 2011-06-28 |
| Date of Event | 2011-06-28 |
| Date Mfgr Received | 2011-06-28 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2012-06-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHEL PIGNATARO, MGR. |
| Manufacturer Street | 911 HANSEN WAY M/S C-255 |
| Manufacturer City | PALO ALTO CA 94304 |
| Manufacturer Country | US |
| Manufacturer Postal | 94304 |
| Manufacturer Phone | 6504246471 |
| Manufacturer G1 | VARIAN MEDICAL SYSTEMS UK LTD. |
| Manufacturer Street | GATWICK RD. |
| Manufacturer City | CRAWLEY, WEST SUSSEX HR109RG |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HR10 9RG |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUITY |
| Generic Name | ACCELERATOR, LINEAR, MEDICAL |
| Product Code | KPQ |
| Date Received | 2011-07-26 |
| Model Number | H77 |
| ID Number | V2.2.9.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS UK LTD. |
| Manufacturer Address | UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-26 |