MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-10-12 for COMPACT ABSORBER * 427002100 manufactured by Ge Healthcare Finland Oy.
[686578]
During the use of the compact absorber, customer reportedly noted high artificial respiration pressure at the pt side. There was no reported pt 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
[7965448]
Ge healthcare is undertaking 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 | 9610105-2006-00038 |
| MDR Report Key | 887372 |
| Report Source | 05 |
| Date Received | 2006-10-12 |
| Date of Report | 2006-10-12 |
| Date of Event | 2006-09-18 |
| Date Mfgr Received | 2006-09-25 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2007-08-01 |
| 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 |
| 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 | 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 | 2006-10-12 |
| Model Number | * |
| Catalog Number | 427002100 |
| Lot Number | 097076 |
| ID Number | SAMPLE #3 |
| 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 | 864882 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | KUORTANEENKATU 2 HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-12 |