MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-23 for SEE DESCRIPTION manufactured by A-dec, Inc..
[26559225]
For shipped product, the manufacturer is contacting customers to notify them of the issue and provide replacement product.
Patient Sequence No: 1, Text Type: N, H10
[26559226]
A quantity of 173 electric power supplies shipped without dielectric testing per iec 60601-1 (2012). These power supplies are designed and manufactured for use with dental equipment. Between july 5 and august 26, 2015, the products passed the functional test and the ground continuity test; however a service error prevented the application of high voltage for the dielectric test. These power supplies were shipped to customers worldwide. 25 watt power supplies: 28. 1479. 00, 28. 1480. 00, 28. 1481. 00. 80 watt power supplies: 47. 2031. 00, 28. 1345. 00. 300 watt power supplies: 43. 0260. 00, 43. 0261. 00, 28. 1435. 00, 28. 1436. 00. The hazard for untested product is electrical damage to equipment, smoke, fire or electrical shock to persons. Due to standard assembly instructions and 100% functional testing, the probability of a hazardous condition is remote. As of the date on this report, there have been no reported field malfunctions. All product within the manufacturer's control was quarantined and subsequently tested. For shipped product, the manufacturer is contacting customers to notify them of the issue and provide replacement product. The malfunctioning dielectric tester (tf804 universal power supply dielectric tester) was repaired on august 26, 2015 and corrective action was taken to ensure the service error could not recur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3015729-2015-00002 |
| MDR Report Key | 5097642 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-23 |
| Date of Report | 2015-09-03 |
| Date of Event | 2015-08-26 |
| Date Mfgr Received | 2015-08-26 |
| Device Manufacturer Date | 2015-08-26 |
| Date Added to Maude | 2015-09-23 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROBERT NAPORA |
| Manufacturer Street | 2601 CRESTVIEW DRIVE |
| Manufacturer City | NEWBERG OR 97132 |
| Manufacturer Country | US |
| Manufacturer Postal | 97132 |
| Manufacturer Phone | 5035389471 |
| Manufacturer G1 | A-DEC, INC. |
| Manufacturer Street | 2601 CRESTVIEW DRIVE |
| Manufacturer City | NEWBERG OR 97132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 97132 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | POWER SUPPLY |
| Product Code | KLC |
| Date Received | 2015-09-23 |
| Catalog Number | SEE DESCRIPTION |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A-DEC, INC. |
| Manufacturer Address | 2601 CRESTVIEW DRIVE NEWBERG OR 97132 US 97132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2015-09-23 |