MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-30 for RUSCH SILICONE REBREATHING BAG 2.3L 150700023 manufactured by Teleflex Medical.
[1951296]
The event is reported as: there was white powder found inside the silkobag. The powder blocked the filter on the anesthesia machine. The entire machine was out of commission as the bellow was blocked and the o-ring had to be cleaned. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[9108614]
Product will not be available for evaluation. A follow-up report will be submitted when investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610520-2011-00002 |
| MDR Report Key | 2068066 |
| Report Source | 06 |
| Date Received | 2011-03-30 |
| Date of Report | 2011-03-07 |
| Date Mfgr Received | 2011-03-07 |
| Date Added to Maude | 2011-05-09 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | WILLY RUESCH GMBH |
| Manufacturer Street | WILLY RUESCH STRASSE 4-10 |
| Manufacturer City | KERNEN 71394 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 71394 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH SILICONE REBREATHING BAG 2.3L |
| Generic Name | REBREATHING BAG |
| Product Code | BYW |
| Date Received | 2011-03-30 |
| Model Number | NA |
| Catalog Number | 150700023 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | KERNEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-30 |