MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-01-10 for DEVILBISS OXYGEN CONSERVING DEVICE PD1000 manufactured by Devilbiss Healthcare Llc.
[3368689]
End user stated she was at home and placed her ocd (oxygen conserving device) on a fresh b-tank around 3:30 pm on (b)(6) 2012. End user approximated the time as she was not exactly sure when this incident occurred. When she took her first breath from the new tank, she stated she felt a slow burn. She went to install another tank and took a second breath from the current o2 setup. The second breath also caused a burning, which she described as breathing in acid and that the smell was harsh. She was able to bring her dog back inside her home and called 911 before passing out. She was taken by ambulance to the hospital where she stated she was placed on a ventilator as part of her treatment. The local branch made several attempts to recover and quarantine the equipment involved but the end user is refusing to return the equipment.
Patient Sequence No: 1, Text Type: D, B5
[10351876]
"(b)(6) has stated that the pt is unwilling to allow them to pick up the equipment for assessment. Apparently the pt had been using the cylinder and conserving device without issue earlier in that same day. At this point we are unable to proceed with any further investigation until the equipment is retrieved by (b)(6). (b)(6) has notified the pt that we will be unable to further investigate this incident without evaluating the equipment. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515872-2013-00003 |
| MDR Report Key | 2921920 |
| Report Source | 06 |
| Date Received | 2013-01-10 |
| Date of Report | 2013-01-10 |
| Date of Event | 2012-12-06 |
| Date Mfgr Received | 2013-01-03 |
| Device Manufacturer Date | 2008-10-20 |
| Date Added to Maude | 2013-01-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BETTY MILLER |
| Manufacturer Street | 100 DEVILBISS DR. |
| Manufacturer City | SOMERSET PA 15501 |
| Manufacturer Country | US |
| Manufacturer Postal | 15501 |
| Manufacturer Phone | 8144437602 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEVILBISS OXYGEN CONSERVING DEVICE |
| Generic Name | PULSE DOSE |
| Product Code | NFB |
| Date Received | 2013-01-10 |
| Model Number | PD1000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEVILBISS HEALTHCARE LLC |
| Manufacturer Address | 100 DEVILBISS DR. SOMERSET PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-10 |