MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-27 for PRESSUREEASY * 292004 manufactured by Smiths Medical.
[20986588]
Cuff pressure regulating device failure. The tubing separated for the pressure feedback adapter and created a large leak from the ventilator circuit. The problem was detected quickly and the device was replaced. No harm came to the patient. The device manufacturer was contacted and 2 defective units were sent in for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3329465 |
| MDR Report Key | 3329465 |
| Date Received | 2013-08-27 |
| Date of Report | 2013-08-27 |
| Date of Event | 2013-08-23 |
| Report Date | 2013-08-27 |
| Date Reported to FDA | 2013-08-27 |
| Date Reported to Mfgr | 2013-09-06 |
| Date Added to Maude | 2013-09-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESSUREEASY |
| Generic Name | ATTACHMENT, BREATHING |
| Product Code | BSK |
| Date Received | 2013-08-27 |
| Returned To Mfg | 2013-08-23 |
| Model Number | * |
| Catalog Number | 292004 |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL |
| Manufacturer Address | 10 BOWMAN DR. KEENE, NH 03431 US 03431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-27 |