MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2009-12-02 for AS/3 M-ESTPR MODULE manufactured by Ge Healthcare Finland, Oy.
[1387998]
A customer reported that during an anesthesia case, the ecg (electrocardiogram), ibp (invasive blood pressure), and spo2 (pulse oximetry), parameters dropped out. The fault was isolated to the m-estpr module as the gas module continued to function as designed. The m-estpr module is a part of the modular anesthesia monitoring system as/3, which provides ecg, spo2, 2 invasive pressure and 2 temperature channels and impedance respiration measurements. Ge healthcare has requested the device be returned for investigation. A follow up report will be filed once the investigation results are available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610105-2009-00035 |
| MDR Report Key | 1556180 |
| Report Source | 01,05,06 |
| Date Received | 2009-12-02 |
| Date of Report | 2009-12-02 |
| Date of Event | 2009-11-06 |
| Date Mfgr Received | 2009-11-09 |
| Device Manufacturer Date | 1997-07-01 |
| Date Added to Maude | 2010-07-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANN LEBAR |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. MAIL CODE - W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482757 |
| 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 | AS/3 M-ESTPR MODULE |
| Generic Name | ELECTROCARDIOGRAPHIC DEVICE |
| Product Code | MLD |
| Date Received | 2009-12-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND, OY |
| Manufacturer Address | HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-02 |