MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,08 report with the FDA on 2011-09-27 for RUSCH STRETCH NECK REBREATH BAG 153000010 manufactured by Teleflex Medical.
[21764891]
The event is reported as: alleged issue: "bag doesn't hold air, air doesn't stay in bag. " no patient injury or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
[21921559]
The device sample was not received by the manufacturer at the time of this report. A follow-up report will be sent when completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8040412-2011-00144 |
| MDR Report Key | 2271984 |
| Report Source | 05,06,07,08 |
| Date Received | 2011-09-27 |
| Date of Report | 2011-09-14 |
| Date of Event | 2011-08-01 |
| Date Mfgr Received | 2011-09-14 |
| Date Added to Maude | 2011-12-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | P.O BOX 28 |
| Manufacturer City | KAMUNTING PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH STRETCH NECK REBREATH BAG |
| Generic Name | ANESTHESIA REBREATHING BAG |
| Product Code | BTC |
| Date Received | 2011-09-27 |
| Catalog Number | 153000010 |
| Lot Number | 4226308IN |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-27 |