MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-08-04 for REUTHER CARBON FIBER TABLETOP (CFT) RM2-4 DO NA manufactured by Reuther Medizintechnick Gmbh & Co. Kg.
[20932583]
Date of event 2006. Customer complaint was received by siemens medical solutions ocs july 14, 2006. Complaint as stated: the event occurred while patient was lying on top of treatment table. "the therapists were positioning the patient, and they ordered him to slide down. While he was doing this, the hed rest fell down and the patient followed it, falling from the table, knocking his head and ending up on the floor. The teflon screws that hold the head rest to the table broke. " questions and response from complainant pertaining to patient involvement: was anyone injured (even slightly? ) yes "extent of injury: head bump, ribs pain and scratch on the knee" see section h10 for additional information. Additional feedback from complainant; "there wa no internal incident report. The patient didn't need other health care than what was supplied after the incident. (minor nursing)".
Patient Sequence No: 1, Text Type: D, B5
[21063734]
Investigation of complaint: the investigation into the head extension breakage included an evaluation by siemens medical solution ocs and our suppliers. Siemens medical solution distributes various carbon fiber tabletops with optional head extensions for use on treatment table distributed by siemens medical solutions. It has come to our attention that this event occurred on a siemens linear accelerator treatment table which had an accessory which was installed and manufactured by reuther medizintechnik gmbh & co. The two mounting rails manufactured and installed by reuther, that mounts to this carbon fiber tabletop (fasten with screws) that hold the head extension in place have broken off. According to the complainant, the patient wa being prepped for treatment and was laying on top of the table top ap while his head and shoulders were over the headrest. His hands were near his body since this was a prostate treatment. The head extension fell just after the patient put the weight of his head on top of it. With the understanding of the known facts thus far, it is the opinion of this group that the root cause on how the screws broke is not clear. In this case, the investigating group is assuming that the type of mounting hardware material (i. E. Plastic versus aluminum) and the type of head extension manufactured and installed by reuther (i. E. Head extension longer than 150mm) may have contributed in the malfunction of the mounting rails. Evaluation: follow up: the investigation is on-going to complete root cause analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2910081-2006-00006 |
| MDR Report Key | 752957 |
| Report Source | 07 |
| Date Received | 2006-08-04 |
| Date of Report | 2006-08-04 |
| Date of Event | 2006-07-11 |
| Date Mfgr Received | 2006-07-24 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2006-08-23 |
| 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 | 3 |
| Manufacturer Contact | DAN TAKEMOTO |
| Manufacturer Street | 4040 NELSON AVENUE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 9256028192 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REUTHER CARBON FIBER TABLETOP (CFT) |
| Generic Name | REUTHER CARBON FIBER TABLETOP (CFT) |
| Product Code | JAI |
| Date Received | 2006-08-04 |
| Model Number | RM2-4 DO |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 740752 |
| Manufacturer | REUTHER MEDIZINTECHNICK GMBH & CO. KG |
| Manufacturer Address | HINTER DER JUNGENSTR. 9 * GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-08-04 |