MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2012-08-20 for RUSCH SILKO REBREATHING BAG, 2.3L 150700023 manufactured by Willy Ruesch Gmbh.
[2931987]
The event is reported as: there are minimal tears at the joint between the hanger and the bag. Due to the tear in the bag, the breathing machine alarmed. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10015437]
The device sample was not received for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610520-2012-00012 |
| MDR Report Key | 2712634 |
| Report Source | 01,05,06,07,08 |
| Date Received | 2012-08-20 |
| Date of Report | 2012-07-31 |
| Date Mfgr Received | 2012-07-31 |
| 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, SPECIALIST |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | WILLY RUESCH GMBH |
| Manufacturer Street | WILLY RUESCH-STR. 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 | 2012-08-20 |
| Catalog Number | 150700023 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLY RUESCH GMBH |
| Manufacturer Address | KERNEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-20 |