MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-09-10 for 7684 LA NA manufactured by Nellcor Puritan Bennett, Inc..
[70975]
Manufacturer representative spoke with caregiver who was concerned about the end barrier on her lift working properly, because her daughter had fallen off the lift. After discussing it furhter, manufacturer representative believed the accident was a result of operator error. Caregiver stands on teh platform and pulls her daughter's wheelchair on and then goes up, one or both wheels were on top of the barriers and did not allow the locked position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183157-1997-00241 |
| MDR Report Key | 120104 |
| Report Source | 07 |
| Date Received | 1997-09-10 |
| Date of Report | 1997-08-11 |
| Date Mfgr Received | 1997-08-11 |
| Device Manufacturer Date | 1990-09-01 |
| Date Added to Maude | 1997-09-18 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 7684 LA |
| Generic Name | AUTOMATIC VAN LIFT |
| Product Code | ING |
| Date Received | 1997-09-10 |
| Model Number | 7684 LA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 117748 |
| Manufacturer | NELLCOR PURITAN BENNETT, INC. |
| Manufacturer Address | 14800 28TH AVE. NORTH PLYMOUTH MN 55447 US |
| Baseline Brand Name | VANGATER LIFT |
| Baseline Generic Name | WHEELCHAIR LIFT |
| Baseline Model No | 7684 LA |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Baseline Device Family | AUTOMATIC VAN LIFT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K900417 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-09-10 |