MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2012-10-30 for RUSCH SILKO REBREATHING BAG, 2.3L 150700023 manufactured by Willy Rusch Gmbh.
[3079669]
The event is reported as: during use on a pt, when the balloon was being inflated, it deflated. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10271440]
The results of the investigation are not available at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610520-2012-00015 |
| MDR Report Key | 2833502 |
| Report Source | 01,05,06,07 |
| Date Received | 2012-10-30 |
| Date of Report | 2012-10-18 |
| Date of Event | 2012-10-15 |
| Date Mfgr Received | 2012-10-18 |
| Date Added to Maude | 2012-12-05 |
| 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 | MARGIE BURTON, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | WILLY RUSCH GMBH |
| Manufacturer Street | WILLY RUSCH STRASSE 4-10 |
| Manufacturer City | KERNEN 71394 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 71394 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH SILKO REBREATHING BAG, 2.3L |
| Generic Name | ANESTHESIA BREATHING BAG |
| Product Code | BYW |
| Date Received | 2012-10-30 |
| Catalog Number | 150700023 |
| Lot Number | P1117405 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLY RUSCH GMBH |
| Manufacturer Address | KERNEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-30 |