MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-03-02 for DEVILBISS DV5 DV54NE-P manufactured by Devilbiss Healthcare Llc.
[101699887]
The devilbiss intellipap model dv53 series standard plus cpap intended use is in the treatment of obstructive sleep apnea syndrome (osa) in spontaneously breathing patients (b)(6) and above by means of application of positive air pressure. The device is intended to be used in home and clinical environments. The cpap model dv54ne-p was evaluated by our engineering department. The investigation reveals evidence of a thermal event that was traced to the oxygen inlet port adapter, which was located at the humidifier flow outlet between the outlet and the cpap supply tubing. The thermal damage patterns indicate the oxygen was flowing into the cpap while the cpap blower was not operating (oxygen flowing into the unit from the gas source but the cpap device was not turned on). Allowing oxygen to flow into the cpap unit that is not operating is contraindicated, as noted in the dv54ne-p user manual se-dv53-2 rev a in the section "warning- oxygen use", which provides clear warning of the danger and risk of fire associated with oxygen flowing into the cpap without the blower operating. The investigation and findings indicate that user did not follow the instructions in the product's user manual.
Patient Sequence No: 1, Text Type: N, H10
[101699888]
As communicated in an email to devilbiss from our ec representative, the distributor based in (b)(6) ((b)(4)) advised about an event associated with a cpap sleepcube, model dv54ne-p. The distributor communicated the following information: "event location: living room the patient in (b)(6). Event description: the device was connected to the power line and the customer left the room in which the device was located. Shortly thereafter, the smoke alarm sounded and the appliance burned according to the message on (or near) the air outlet of the humidifier. " in a subsequent communication with the distributor, it was confirmed that the cpap unit was connected to an oxygen source; and "there was no injury on the patient and may have been a wrong intend of usage. " it was also confirmed the device was not being used for treatment and/or for diagnosis when the incident happened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515872-2018-00004 |
| MDR Report Key | 7310969 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-03-02 |
| Date of Report | 2018-02-02 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-02-02 |
| Device Manufacturer Date | 2012-02-28 |
| Date Added to Maude | 2018-03-02 |
| 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 |
| Product Code | LEL |
| Date Received | 2018-03-02 |
| Returned To Mfg | 2018-02-13 |
| Model Number | DV5 |
| Catalog Number | DV54NE-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 | 2018-03-02 |