MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-03-07 for 9684 VANGATER II LIFT NA manufactured by Aequitron Medical, Inc..
[47381]
When user was on lift, inside vehicle and starting the slow-function, user reportedly broke his leg. User was transported to hosp and later released and is currently using the lift. Unable to determine how injury to user occurred.
Patient Sequence No: 1, Text Type: D, B5
[22047584]
H3) testing by mfr found a broken down-stop wire. The down-stop wire was repaired. The broken down-stop wire could not have contributed to the lift's inadvertent operation. H6) adjusted codes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183897-1997-00003 |
| MDR Report Key | 75621 |
| Report Source | 07 |
| Date Received | 1997-03-07 |
| Date of Report | 1997-02-06 |
| Date of Event | 1997-01-11 |
| Date Mfgr Received | 1997-02-06 |
| Device Manufacturer Date | 1996-10-01 |
| Date Added to Maude | 1997-03-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 9684 VANGATER II LIFT |
| Generic Name | AUTOMATIC VAN LIFT |
| Product Code | ING |
| Date Received | 1997-03-07 |
| Model Number | 9684 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 75378 |
| Manufacturer | AEQUITRON MEDICAL, INC. |
| Manufacturer Address | 14800 28TH AVENUE NORTH PLYMOUTH MN 55447 US |
| Baseline Brand Name | VANGATER II LIFT |
| Baseline Generic Name | WHEELCHAIR LIFT |
| Baseline Model No | 9684 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | AUTOMATIC VAN LIFT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K952946 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1997-03-07 |