MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2013-09-05 for MULTI ABSORBER ORIGINAL, DISPOSABLE M1173310 manufactured by Ge. Healthcare Finland Oy.
[15783939]
It was reported that a hole in the multi absorber allowed for leakage preventing adequate oxygen/anesthesia flow to the patient. The customer reported the patient was sedated and intubated at 1820. At 1822, delivery of sevoflurane was started. At 1825, patient blood pressure dropped from, "130's/70's to 90/40. " subsequently, the patient was manually ventilated with an ambu bag during trouble shooting. Air was heard coming from the anesthesia machine. The multi absorber was changed but the problem persisted. The anesthesia machine was replaced, but the difficulty continued. The multi absorber was changed again on the second anesthesia machine and the patient "recovered to a normal bp at 1837. " no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[15973696]
No patient information has been provided. The customer initially reported that a sample was returned to ge healthcare. To date, no sample has been provided. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2013-00015 |
| MDR Report Key | 3342411 |
| Report Source | 00,05,06 |
| Date Received | 2013-09-05 |
| Date of Report | 2013-08-12 |
| Date of Event | 2013-06-25 |
| Date Mfgr Received | 2013-08-12 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2013-09-19 |
| 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 | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE HEALTHCARE FINLAND OY |
| Manufacturer City | HELSINKI |
| Manufacturer Country | FI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI ABSORBER ORIGINAL, DISPOSABLE |
| Generic Name | ABSORBER, CARBON-DIOXIDE |
| Product Code | BSF |
| Date Received | 2013-09-05 |
| Model Number | M1173310 |
| Lot Number | 13029 |
| Device Expiration Date | 2015-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE. HEALTHCARE FINLAND OY |
| Manufacturer Address | HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-05 |