MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-06-07 for SMR CART OTOSCOPE AND VACUUM 160000 manufactured by Storz Instrument Co..
[9001]
When handpiece is raised from the cradle, the suction (vacuum) motor automatically turns on. Unless it is turned off, it will run until it gets very hot. If the problem was caused by static build-up, if the static discharged at night, the motor would run all night until someone turns it off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1002381 |
| MDR Report Key | 13841 |
| Date Received | 1994-06-07 |
| Date of Report | 1994-05-04 |
| Date of Event | 1994-02-10 |
| Date Added to Maude | 1994-06-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMR CART OTOSCOPE AND VACUUM |
| Generic Name | OTOSCOPE AND VACUUM |
| Product Code | ERA |
| Date Received | 1994-06-07 |
| Model Number | 160000 |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13839 |
| Manufacturer | STORZ INSTRUMENT CO. |
| Manufacturer Address | ST LOUIS MO 63122 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-06-07 |