MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1998-09-03 for AMSCO 2080IA SURGICAL TABLE TC-800 manufactured by Steris Corp..
[98656]
At the conclusion of a gall bladder laparoscopy, with the procedure completed and the pt on the table in reverse pt orientation, awaiting a c-arm x-ray, the pt went into cardiac arrest. Surgical assistant performed cpr-like chest compressions by standing to the right side of the pt's upper torso, for approx 3-4 minutes (an estimated 50 compressions), stopped for the anesthesiologist to check pt, restarted compressions, when an audible "pop" was heard. The section of the table with the pt's upper torso, went down to the floor. Pt was immediately removed from the table. It was stated by the surgical assistant that the pt was breathing when he was removed. In a telephone conversation with the facility risk manager on 8/19/98 he stated that an mri taken after the event revealed that the pt did not sustain any fractures or other identifiable injuries as a result of the fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-1998-00009 |
| MDR Report Key | 186386 |
| Report Source | 05,06,07 |
| Date Received | 1998-09-03 |
| Date of Report | 1998-08-12 |
| Date of Event | 1998-08-12 |
| Date Mfgr Received | 1998-08-12 |
| Device Manufacturer Date | 1987-06-01 |
| Date Added to Maude | 1998-09-11 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMSCO 2080IA SURGICAL TABLE |
| Generic Name | SURGICAL TABLE |
| Product Code | FSE |
| Date Received | 1998-09-03 |
| Model Number | 2080IA |
| Catalog Number | TC-800 |
| Lot Number | NA |
| ID Number | BE56-727-000-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 179436 |
| Manufacturer | STERIS CORP. |
| Manufacturer Address | 2720 GUNTER PARK DRIVE E MONTGOMERY AL 36109 US |
| Baseline Brand Name | AMSCO 2080IA SURGICAL TABLE |
| Baseline Generic Name | SURGICAL TABLE |
| Baseline Model No | 2080IA |
| Baseline Catalog No | TC-800 |
| Baseline ID | BE56-727-000-02 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-09-03 |