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 DV54UK-P manufactured by Devilbiss Healthcare Llc.
[99775543]
The devilbiss healthcare's (b)(4) distributor reported that a cpap unit, model dv54uk-p serial (b)(4), with heater model dv5hh serial (b)(4), and smartlink model sv5m serial (b)(4) were returned by the patient. The (b)(4) distributor initially reported that patient's cpap "began to smoke in the night and [smoke] came through the mask. " however, upon further communication between (b)(4) distributor and the patient, it was determined the unit stopped operating once the smoke started and the patient had no complaint of injury or health-related issues due to the incident. The unit was returned to devilbiss healthcare and an engineering inspection and evaluation was performed. The results of that investigation indicated that the cpap unit failure was caused by a liquid substance onto/ into the electronic assembly. The unit was in use for about 12 months and the liquid substance on the electronic assembly was likely caused by a spill when in use.
Patient Sequence No: 1, Text Type: N, H10
[99775544]
Devilbiss healthcare's (b)(4) distributor reported a cpap unit, model dv54uk-p, malfunctioned and "caused minor respiratory irritation to the patient". Patient arrived at the hospital with his cpap unit but there was no indication of the patient was admitted to the hospital. The (b)(6) distributor stated the patient reported "the cpap unit had stopped functioning and smoke started to come out through the mask. It was at this point the cpap device stopped working".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515872-2018-00002 |
| MDR Report Key | 7237597 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-02-02 |
| Date of Report | 2017-12-01 |
| Date of Event | 2017-11-21 |
| Date Mfgr Received | 2017-12-01 |
| Device Manufacturer Date | 2016-02-04 |
| 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 | INTELLIPAP UNIT |
| Product Code | LEL |
| Date Received | 2018-02-02 |
| Returned To Mfg | 2017-12-12 |
| Model Number | DV54UK-P |
| Operator | LAY USER/PATIENT |
| 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 |