MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-10-10 for ARCO TABLE NT 0055 manufactured by Arcoma Ab.
[3849065]
In conjunction with service / adjustment of the equipment (arco table), it was discovered that the nuts on the table frame were loose.
Patient Sequence No: 1, Text Type: D, B5
[11211672]
In our investigation we have come to the following conclusion; in the assembling instruction of the equipment in question it is stated that the nuts must be tightened with 30 nm. This operation has not been done with this particular unit due to a failure of our internal process. During assembling of the table there has been as assembler shift. At the shift, it has not been secured where the first assembler left off and where the second assembler should continue. When investigating the incident, it has shown that the risk for the patient is very low. Tests carried out by the absence of screws indicate that use of the table under normal conditions (where the patient and user assumes the table's long side) no patient risks occur. If the patient is placed on the table's short side with the table top at its extended maximum i. E. At its outer end position, patient risk can occur. For this to happen it takes that both screws on the opposite shortside is out. However, the absence of screws makes the table top very wobbly and rickerly. The user will notice that the table is not working as intended. The likelihood of both nuts becoming loose and that both screws falls out without noticing is very low. Investigation of the tables device history records shows that it is not normal procedure to change assembler during manufacturing. The same assembler finalizes his work with the table before it is moved on to the next step in the production process. The probability that there would be more tables with the same problem is assessed as very low.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616014-2013-00001 |
| MDR Report Key | 3457842 |
| Report Source | 00 |
| Date Received | 2013-10-10 |
| Date of Report | 2013-09-11 |
| Date of Event | 2013-09-01 |
| Date Mfgr Received | 2013-09-11 |
| Date Added to Maude | 2014-01-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELISABETH LUNDAHL |
| Manufacturer Street | ANNAVAGEN 1 |
| Manufacturer City | VAXJO SE-352 46 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-352 46 |
| Manufacturer Phone | 70706900 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCO TABLE NT 0055 |
| Generic Name | TABLE, RADIOGRAPHIC, NON-TILTING, POWERED |
| Product Code | IZZ |
| Date Received | 2013-10-10 |
| Model Number | 0055 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARCOMA AB |
| Manufacturer Address | ANNAVAGEN 1 VAXJO S-35246 SW S-35246 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-10 |