MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-12 for CYLINDER,ULTRAFILL,MD22,3000 PSI 1065721 manufactured by Philips Respironics Inc..
[178786210]
The manufacturer received information alleging a cylinder became disconnected from the ultrafill device. There was no report of patient harm or injury. The device has yet to be returned to the manufacturer for evaluation. A follow up report will be filed when the manufacturer has completed the investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2020-00337 |
| MDR Report Key | 9699553 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-12 |
| 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 | ADAM PRICE |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal | 15668 |
| Manufacturer G1 | PHILIPS RESPIRONICS INC. |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15668 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYLINDER,ULTRAFILL,MD22,3000 PSI |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-02-12 |
| Model Number | 1065721 |
| Catalog Number | 1065721 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS INC. |
| Manufacturer Address | 1001 MURRY RIDGE LANE MURRYSVILLE PA 15668 US 15668 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |