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 |