MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-04 for PURITAN AIR FLOWMETER SERIES C 6-124541-00 manufactured by Puritan Bennett.
[1870939]
Rec'd a customers medwatch stating; "when the flowmeter was inserted into the oxygen outlet in the wall, the top of the flowmeter popped off along with other small pieces and flew into the surrounding bed area. Our bio-tech staff estimated that it's at least 20 years old". No adverse event to pt.
Patient Sequence No: 1, Text Type: D, B5
[9110958]
As per customer device is at least 20 years old. Multiple attempts to try and retrieve further info. Should further info become available a f/u up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024500-2011-00007 |
| MDR Report Key | 2057211 |
| Report Source | 06 |
| Date Received | 2011-03-04 |
| Date of Report | 2011-02-14 |
| Date of Event | 2011-01-02 |
| Date Mfgr Received | 2011-02-14 |
| Date Added to Maude | 2011-05-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LISA CARDENAS |
| Manufacturer Street | 2101 FARADAY AVE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7606035073 |
| Manufacturer G1 | PURITAN BENNETT CORP |
| Manufacturer Street | 5931 PRIESTLY DR. |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURITAN AIR FLOWMETER |
| Generic Name | PRESSURE COMPENSATED FLOWMETER |
| Product Code | CAX |
| Date Received | 2011-03-04 |
| Model Number | SERIES C |
| Catalog Number | 6-124541-00 |
| ID Number | RX201102-2089 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PURITAN BENNETT |
| Manufacturer Address | 5931 PRIESTLY DR. CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-04 |