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 2007-03-23 for PERCUPUMP ARTICULATING ARM MOUNTING ACCESSORY 5787 manufactured by Mavig.
[603165]
It was reported that the ceiling mount arm broke and fell on the radiology technician while removing the iv line on the pt. The technician was hit on the back of her head. She was admitted by emergency and released approximately 3 hours later the same day. The technician did not appear to have suffered any serious injury. As of 02/23/2007, the technician had not reported back to work yet.
Patient Sequence No: 1, Text Type: D, B5
[7822868]
A rep from another country mfr visited the user facility. The hospital did not allow removal of the device; however, detailed pictures were taken for the investigation process. This articulating arm was connector to an older injector unit which is no longer manufactured. The model 5787 articulating arm (manufactured by mavig) is no longer in manufacture. The model was estimated to be over 5 years old. Visual analysis of the photos was performed by reps from mfr's regulatory and engineering departments. The potential reason for this failure is a result of repeating swing of the arm contacting the ceiling mount column. A piece of the articulating arm that broke off was still connected to the ceiling mount. The rigid area of the articulating arm comes in contact with the ceiling mount column slowly causing the arm to fracture which eventually causes breakage. The articulating arm failed due to fatigue and constant wear and tear concentrated at a specific area. Based on this investigation, the likely cause is due to user abuse, fatigue, and wear and tear over an extended period. A replacement arm was sent to the customer. The design of the replacement is stronger and more robust and is able to better withstand user abuse.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2411512-2007-00003 |
| MDR Report Key | 835831 |
| Report Source | 05,06,07 |
| Date Received | 2007-03-23 |
| Date of Report | 2007-02-21 |
| Date of Event | 2007-02-20 |
| Date Facility Aware | 2007-02-20 |
| Report Date | 2007-02-21 |
| Date Reported to Mfgr | 2007-02-21 |
| Date Mfgr Received | 2007-02-21 |
| Date Added to Maude | 2007-04-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GINA VOGELSBERG |
| Manufacturer Street | 1111 MARCUS AVE |
| Manufacturer City | LAKE SUCCESS NY 11042 |
| Manufacturer Country | US |
| Manufacturer Postal | 11042 |
| Manufacturer Phone | 5163338230 |
| Manufacturer G1 | MAVIG |
| Manufacturer Street | 25 HYTEC CIRCLE |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14606 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCUPUMP ARTICULATING ARM MOUNTING ACCESSORY |
| Generic Name | INJECTOR MOUNTING ACCESSORY |
| Product Code | FIH |
| Date Received | 2007-03-23 |
| Model Number | NA |
| Catalog Number | 5787 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 823128 |
| Manufacturer | MAVIG |
| Manufacturer Address | * ROCHESTER NY * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-23 |