MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for VIDEO CART 230VAC VP8501 manufactured by Touchpoint Medical.
[140004771]
Complaint confirmed. Evaluation by the service & logistics manager found the bolt stripped the threads from the plate. He also indicated that as standard practice, the bolts are not checked before dispatch however, if 7 of the 8 bolts were missing, the user would have noticed it when it was moved from their loading bay. The service history could not be reviewed as a serial number was not provided. The dhr could not be reviewed as a serial number was not provided. Manufacture date could not be determined as a serial number was not provided. A two-year review of complaint history revealed there has been 5 complaints regarding 5 devices for this device family and failure mode. During the same time frame 369 devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed, the rate of failure would be. 01 per the instructions for use, the user is advised the following; conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected. When moving the cart push don't pull. Use handles only to move the cart. Use care when moving the cart. Ensure all components are in their transport position as described in "configuring cart for transportation" section. Ensure the caster locks are released and the path is clear of obstacles. Overbalancing tip hazard: take caution when moving, pushing or leaning on the cart. Exercise caution when moving cart on inclined surfaces and/or over bumps like cords, door thresholds, elevator doorways or cracks. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[140004772]
The customer reported that the monitor arm of the vp8501, video cart, during a trial run, swung on its own off to one side and caused the monitor to strike a staff member in the arm causing some minor bruising. The staff member did not require any medical treatment and her status is fine. The entire unit came crashing to the floor. This report is being raised based on device malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2019-00036 |
| MDR Report Key | 8437433 |
| Date Received | 2019-03-20 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-02-05 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-03-20 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MELANIE HANSEN |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | TOUCHPOINT MEDICAL |
| Manufacturer Street | 114 DOUGLAS ROAD E |
| Manufacturer City | OLDSMAR FL 346772939 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 346772939 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIDEO CART 230VAC |
| Generic Name | VIDEO CART |
| Product Code | KQM |
| Date Received | 2019-03-20 |
| Returned To Mfg | 2019-02-27 |
| Model Number | VP8501 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOUCHPOINT MEDICAL |
| Manufacturer Address | 114 DOUGLAS ROAD E OLDSMAR FL 346772939 US 346772939 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-20 |