MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-31 for S/5 ANESTHESIA MONITOR manufactured by Ge Healthcare Finland Oy.
[16865249]
The customer reported the s5 anesthesia monitor did not audibly alarm for a "straight line" ecg waveform. The clinicians who were present in the operating room at the time in question immediately saw the "straight line" ecg and responded to the patient's condition by performing cardiopulmonary resuscitation measures. The patient has anoxic encephalopathy as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
[16929026]
A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2012-00041 |
| MDR Report Key | 2820307 |
| Report Source | 05,06 |
| Date Received | 2012-10-31 |
| Date of Report | 2012-10-03 |
| Date of Event | 2012-09-20 |
| Date Mfgr Received | 2012-10-03 |
| Device Manufacturer Date | 2002-10-01 |
| Date Added to Maude | 2013-02-06 |
| 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 | BIOMEDICAL ENGINEER |
| 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. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE HEALTHCARE |
| Manufacturer City | HELSINKI |
| Manufacturer Country | FI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S/5 ANESTHESIA MONITOR |
| Generic Name | PATIENT MONITOR |
| Product Code | CBQ |
| Date Received | 2012-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-10-31 |