MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-10-11 for COMPACT ABSORBER * manufactured by Ge Healthcare Finland Oy.
[677452]
Customer reported difficulty ventilating patient. There was no reported patient injury. Customer stated they have received ge healthcare's urgent medical device recall letter, dated september 2006 (copy attached), and have discarded the affected compact absorbers. No sample could be provided to ge healthcare for investigation.
Patient Sequence No: 1, Text Type: D, B5
[7977919]
Evaluation: customer reportedly discarded sample; therefore, there was no sample available for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2006-00035 |
| MDR Report Key | 883541 |
| Report Source | 05 |
| Date Received | 2006-10-11 |
| Date of Report | 2006-10-11 |
| Date of Event | 2006-09-18 |
| Date Mfgr Received | 2006-09-18 |
| Date Added to Maude | 2007-07-24 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANN LEBAR |
| Manufacturer Street | 9900 INNOVATION DRIVE MAIL STOP: RP2138 |
| Manufacturer City | WAUWATOSA WI 53226 |
| Manufacturer Country | US |
| Manufacturer Postal | 53226 |
| Manufacturer Phone | 4147213947 |
| Manufacturer G1 | GE HEALTHCARE FINLAND OY |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | FI |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPACT ABSORBER |
| Generic Name | CARBON DIOXIDE ABSORBER |
| Product Code | BSF |
| Date Received | 2006-10-11 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 862011 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | KUORTANEENKATU 2 HELSINKI FI FN-00510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-11 |