MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-09-08 for COMPACT ABSORBER * 427002100 manufactured by Ge Healthcare Finland Oy.
[520160]
Customer reportedly noted high resistance in the compact absorber canister. There was no report patient injury. Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
[7795517]
Ge healthcare plans to undertake a field correction to address this condition. Details of the field correction will be submitted in the report of corrections and removals as required by 21 cfr 806.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2006-00028 |
| MDR Report Key | 776729 |
| Report Source | 05 |
| Date Received | 2006-09-08 |
| Date of Report | 2006-09-08 |
| Date of Event | 2006-08-01 |
| Date Mfgr Received | 2006-08-22 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2006-11-07 |
| 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 DR MAIL STOP: RP2138 |
| Manufacturer City | MAUWATOSA WI 53226 |
| Manufacturer Country | US |
| Manufacturer Postal | 53226 |
| Manufacturer Phone | 4147213947 |
| Manufacturer G1 | GE HEALTHCARE FINLAND OY |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| 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 | 2006-09-08 |
| Model Number | * |
| Catalog Number | 427002100 |
| Lot Number | 090076 |
| ID Number | * |
| Device Expiration Date | 2008-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 764506 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | KUORTANEENKATU 2 HELSINKI FI FIN-00510 |
| Baseline Brand Name | DATEX-OHMEDA COMPACT ABSORBER, DISPOSABLE |
| Baseline Generic Name | ABSORBER |
| Baseline Model No | 427002100 |
| Baseline Catalog No | 427002100 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-08 |