MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-17 for ADEC 1040 WITH CASCADE manufactured by Adec.
[18912927]
While using an adec dental chair model 1040 with the cascade delivery system, an attached water bottle exploded. The water bottle provides sanitized water under pressure to the dental syringe unit for rinsing of the mouth of a pt. The force of the explosion was strong enough to completely fracture the adjacent plastic molded cowling that covered mechanical components of the chair. Lucky circumstance is that no pt was on the chair at the time. It was determined that a kit had been improperly installed sometime in the past, resulting in a missing pressure regulator, that caused dangerous pressures in the water bottle on the chair. Also, the water bottle -adec model 052-018-00- has been redesigned and replaced with a new bottle that can handle high pressures. If the combination of the old bottle and an incorrect installation occurs, the water bottle will explode at some random time in the future. Event abated after use stopped or dose reduced? Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007679 |
| MDR Report Key | 1078241 |
| Date Received | 2008-07-17 |
| Date of Report | 2008-07-17 |
| Date of Event | 2008-07-14 |
| Date Added to Maude | 2008-07-24 |
| 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 | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADEC |
| Generic Name | DENTAL CHAIR |
| Product Code | KLC |
| Date Received | 2008-07-17 |
| Model Number | 1040 WITH CASCADE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1046228 |
| Manufacturer | ADEC |
| Manufacturer Address | 2601 CRESTVIEW DR. OR 97132 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-17 |