MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-02-02 for DEVILBISS DV51UK manufactured by Devilbiss Healthcare, Llc.
[99089617]
The incident was reported to devilbiss healthcare's (b)(4) distributor of the device who stated there was "damage to the connection of the (j8) ac voltage power connector to printed circuit board (pcb)". The (b)(4) distributor noted that the (j8) ac voltage power connector was arcing and that it was cold soldered to the printed circuit board (pcb) board. The (b)(4) distributor reported there appeared to be damage to the solder joint and the damage was more than likely caused by excessive force or mechanical stress applied to the connector. The unit was returned to devilbiss healthcare and an engineering inspection and evaluation was performed, which confirmed that the cpap unit had a cold solder joint between the printed circuit board (pcb) and the (j8) ac voltage power connector. The cold solder joint was the result of improper welding technique during the electronic assembly process of the printed circuit board (pcb). This is localized to the position on the board and internal to the device. Devilbiss healthcare has notified the printed circuit board (pcb) manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[99089618]
The devilbiss healthcare's (b)(4) distributor reported the cpap dv51uk,'s (j8) ac voltage power connector soldered to the internal printed circuit board (pcb) was arcing. The (b)(4) distributor reported there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515872-2018-00003 |
| MDR Report Key | 7237591 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-02-02 |
| Date of Report | 2017-12-18 |
| Date of Event | 2016-06-08 |
| Date Mfgr Received | 2017-01-25 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2018-02-02 |
| 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 | MS. FIGUEROA |
| Manufacturer Street | 100 DEVILBISS DRIVE |
| Manufacturer City | SOMERSET PA 15501 |
| Manufacturer Country | US |
| Manufacturer Postal | 15501 |
| Manufacturer Phone | 8003381988 |
| Manufacturer G1 | DEVILBISS HEALTHCARE LLC |
| Manufacturer Street | 100 DEVILBISS DRIVE |
| Manufacturer City | SOMERSET PA 15501 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEVILBISS |
| Generic Name | CPAP |
| Product Code | LEL |
| Date Received | 2018-02-02 |
| Returned To Mfg | 2017-11-27 |
| Model Number | DV51UK |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEVILBISS HEALTHCARE, LLC |
| Manufacturer Address | 100 DEVILBISS DRIVE SOMERSET PA 15501 US 15501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-02 |