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 |