MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-11-17 for BRAND NAME 9684 PF manufactured by Nellcor Puritan Bennett.
[112330]
Event description as reported by customer. User stated about a month ago he has an accident on his lift. User reiterated that the incident was not the fault of the lift but believes it resulted from him inadvertently activating the radio remote transmitter. On 10/3/97, he was using a circuitron radio remote control and was exiting his van and entering onto the platform. When his front wheels were on the platform, it began moving down. He gunned his chair and it did make it all the way onto the platform. However, because of the rate of speed at which he entered onto the platform, the front barrier stopped him abruptly. He was not wearing his seat belt that was on the chair and fell out onto the pavement. He sustained a broken leg, fractured hip, cuts above his eye and lip which required stiches. He said that they modified the wiring on his lift so it will deploy while still tri-folded and used a separate remote control for that function. Co has since removed this remote control, but still use the circuitron remote. Co said co never had such symptoms before or after the incident. Co does use the radio remote transmitter while on the platform which the mfr warns against.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183897-1997-00009 |
| MDR Report Key | 134028 |
| Report Source | 04 |
| Date Received | 1997-11-17 |
| Date of Report | 1997-11-04 |
| Date of Event | 1997-10-03 |
| Date Mfgr Received | 1997-11-04 |
| Device Manufacturer Date | 1996-08-01 |
| Date Added to Maude | 1997-11-25 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRAND NAME 9684 PF |
| Generic Name | AUTOMATIC VAN LIFT |
| Product Code | ING |
| Date Received | 1997-11-17 |
| Model Number | 9684 PF |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 130987 |
| Manufacturer | NELLCOR PURITAN BENNETT |
| Manufacturer Address | 14800 28TH AVENUE NORTH PLYMOUTH MN 55447 US |
| Baseline Brand Name | BRAND NAME 9684 PF |
| Baseline Generic Name | AUTOMATIC VAN IFT |
| Baseline Model No | 9684 PF |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1997-11-17 |