MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-13 for HOVERMATT MEDICAL CARTS HMC-100 manufactured by Hovertech International.
[94721979]
Patient Sequence No: 1, Text Type: N, H10
[94721980]
Staff member was removing the hovermatt and cart out of a patient's room and into the hallway. She was walking with the cart to the storage area and hovermatt cart tipped over while she was holding onto the cart and fell to the ground with the cart. She hit her left knee and left side of forehead on floor. In seconds, other staff arrived to situation and injured person was not arousable for approximately 30-45 seconds with breathing and with pulse. With gentle shaking she opened her eyes and complained of left side of forehead hurting and left knee hurting, blood pressure hypertensive at 150-160s and finger stick 151. House supervisor and rapid response team notified, assisted staff up from floor with hover jack and placed in hospital bed and taken to emergency department to be evaluated. There have been numerous reports of this model cart tipping over. The wheel spacing is very narrow and the center of gravity is offset. There is a newer model of cart with 6 wheels (hovermatt universal cart, hmc-u) which is much more stable and far less likely to tip over.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7112346 |
| MDR Report Key | 7112346 |
| Date Received | 2017-12-13 |
| Date of Report | 2017-12-08 |
| Date of Event | 2017-12-05 |
| Report Date | 2017-12-08 |
| Date Reported to FDA | 2017-12-08 |
| Date Reported to Mfgr | 2017-12-08 |
| Date Added to Maude | 2017-12-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOVERMATT MEDICAL CARTS |
| Generic Name | DEVICE, PATIENT TRANSFER, POWERED |
| Product Code | FRZ |
| Date Received | 2017-12-13 |
| Model Number | HMC-100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOVERTECH INTERNATIONAL |
| Manufacturer Address | 4482 INNOVATION WAY ALLENTOWN PA 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-12-13 |