MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-05-28 for ECT TABLE 4449278 03286 manufactured by Siemens Medical Systems, Inc. Nmg Group.
[84703]
A 200 kg. Pt was lying on an ect table for a cardiac single photon emmision computed tomography study when the table broke across the width, depositing the pt on the floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423253-1998-00004 |
| MDR Report Key | 170020 |
| Report Source | 07 |
| Date Received | 1998-05-28 |
| Date of Report | 1998-05-26 |
| Date of Event | 1998-03-30 |
| Date Mfgr Received | 1998-04-28 |
| Device Manufacturer Date | 1988-01-01 |
| Date Added to Maude | 1998-06-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECT TABLE |
| Generic Name | ALUMINUM PALLET |
| Product Code | INW |
| Date Received | 1998-05-28 |
| Returned To Mfg | 1998-05-01 |
| Model Number | 4449278 |
| Catalog Number | 03286 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 165380 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS, INC. NMG GROUP |
| Manufacturer Address | 2501 N. BARRINGTON RD. HOFFMAN ESTATES IL 60195 US |
| Baseline Brand Name | ECT TABLE |
| Baseline Generic Name | PALLET |
| Baseline Model No | 4449278 |
| Baseline Catalog No | 03286 |
| Baseline ID | NA |
| Baseline Device Family | ALUMINUM PALLET |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1998-05-28 |