MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-02-21 for AUTOMATIC VAN LIFT 7684 CA NA manufactured by Aequitron Medical, Inc..
[41305]
Report from dealer that a mounting brace broke while user was on the lift platform resulting in user falling off lift in her wheelchair. User was examined at hosp and released. No allegation of injury made.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2183897-1997-00001 |
MDR Report Key | 71447 |
Report Source | 07 |
Date Received | 1997-02-21 |
Date of Report | 1997-01-22 |
Date Mfgr Received | 1997-01-22 |
Device Manufacturer Date | 1994-10-01 |
Date Added to Maude | 1997-02-28 |
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 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AUTOMATIC VAN LIFT |
Generic Name | AUTOMATIC VAN LIFT |
Product Code | ING |
Date Received | 1997-02-21 |
Model Number | 7684 CA |
Catalog Number | NA |
Lot Number | NA |
ID Number | NA |
Device Availability | * |
Device Age | 2 YR |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 71342 |
Manufacturer | AEQUITRON MEDICAL, INC. |
Manufacturer Address | 14800 28TH AVE. NORTH PLYMOUTH MN 55447 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 1997-02-21 |