MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-06-22 for COUCHMOUNT VARIAN EXACT * 40100-0A manufactured by Brainlab Ag.
[15038314]
Medical center reported that their brainlab couchmount attached to the varian couch unintentionally detached from the couchmount and fell on the floor when the patient tried to sit up.
Patient Sequence No: 1, Text Type: D, B5
[15235368]
Problem: the secondary locking mechanism on the couchmount is under certain conditions not reliable. Root cause: protruding magnets of the couch caused the secondary locking mechanism of the brainlab couchmount not to engage reliably. Corrective action: the magnets on the couch at the concerned medical center have been adjusted and the brainlab couchmount now sits flush to the couch and accordingly works reliably. Preventive actions: all couchmount customers will be informed to verify that their couchmount is locked reliably to the couch. The corresponding brainlab user manual will be updated to clearly describe the importance of this check. The design of the couchmount will be improved to clearly indicate when the secondary locking mechanism is engaged/reliable or not.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043933-2005-00002 |
| MDR Report Key | 744439 |
| Report Source | 05,06 |
| Date Received | 2005-06-22 |
| Date of Report | 2005-05-23 |
| Date Mfgr Received | 2005-05-23 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2006-08-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PER PERSSON |
| Manufacturer Street | AMMERTHALSTRASSE 8 |
| Manufacturer City | HEIMSTETTEN 85551 |
| Manufacturer Country | GM |
| Manufacturer Postal | 85551 |
| Manufacturer Phone | 899915680 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COUCHMOUNT VARIAN EXACT |
| Generic Name | COUCHMOUNT FOR RADIOTHERAPY COUCH |
| Product Code | JAI |
| Date Received | 2005-06-22 |
| Model Number | * |
| Catalog Number | 40100-0A |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 732246 |
| Manufacturer | BRAINLAB AG |
| Manufacturer Address | AMMERTHALSTRASSE 8 HEIMSTETTEN GM 85551 |
| Baseline Brand Name | COUCHMOUNT VARIAN EXACT |
| Baseline Generic Name | COUCHMOUNT FOR RADIOTHERAPY COUCH |
| Baseline Model No | * |
| Baseline Catalog No | 40100-0A |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-22 |