MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-10 for CONNEXION IMAGING MODULE P10105-210 manufactured by Medical Intelligence Medizintechnik Gmbh.
[105309900]
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Patient Sequence No: 1, Text Type: N, H10
[105309901]
The customer reported whilst positioning a patient, the middle section of the tabe top broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710332-2018-00001 |
| MDR Report Key | 7410597 |
| Date Received | 2018-04-10 |
| Date of Report | 2018-06-14 |
| Date Mfgr Received | 2018-03-12 |
| Date Added to Maude | 2018-04-10 |
| 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 | PMS |
| Manufacturer Street | LINAC HOUSE FLEMMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Manufacturer G1 | MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
| Manufacturer Street | ROBERT-BOSCH-STR. 8 |
| Manufacturer City | SCHWABM 86830 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 86830 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONNEXION IMAGING MODULE |
| Generic Name | SYSTEM, PLANNING, RADIATION THERAPY TREATMENT |
| Product Code | IXQ |
| Date Received | 2018-04-10 |
| Model Number | P10105-210 |
| Catalog Number | P10105-210 |
| Lot Number | P10105-210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
| Manufacturer Address | ROBERT-BOSCH-STR. 8 SCHWABMUNCHEN,, 86830 GM 86830 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-10 |