MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-05-24 for CARESCAPE CENTRAL STATION manufactured by Critikon De Mexico S. De R.l. De C.v..
[75891196]
Patient information not provided due to country privacy laws. The initial reporter is located outside the united states and therefore this information is not provided due to country privacy laws. Ge healthcare's investigation of the event is ongoing at this time. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[75891197]
It was reported a pacemaker was unnecessarily implanted in a patient (patient 2) based on another patient's (patient 1) ecg event data. The patient underwent another procedure to remove the pacemaker. The patient survived the event.
Patient Sequence No: 1, Text Type: D, B5
[113775719]
Ge healthcare's investigation of the reported issue is as follows: a male (patient 1) with atrioventricular block grade iii was taken off telemetry for a pacemaker procedure on (b)(6) 2017. Patient 1 was not discharged from telemetry with the assumption that the patient would return after the procedure; however, patient 1 did not return to the same care unit/telemetry transmitter. One day later, the same telemetry transmitter was used on a female (patient 2) without discharging the previous patient (patient 1). It was noted the two patients had similar family names. The telemetry server and central station log files were provided for device evaluation; the actual device was not made available by the customer. Device log files confirmed that clinicians did not discharge the previous telemetry patient (patient 1) prior to connecting the female patient (patient 2) to the same transmitter. The female patient (patient 2) was unnecessarily treated with surgical implantation of a dual chamber pacemaker based on ecg telemetry data from the previous patient; the patient required removal of the pacemaker and survived the event. The log file review confirmed that the system performed to specifications; ge healthcare identified no malfunction of the telemetry system. Device labeling provides instructions on the process to admit a patient and warns that the operator should verify patient identification when reviewing patient data.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008729547-2017-00006 |
| MDR Report Key | 6589201 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-05-24 |
| Date of Report | 2017-08-01 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-07-20 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2017-05-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTOF SOOS |
| Manufacturer Street | 8200 W. TOWER AVE |
| Manufacturer City | MILWAUKEE WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARESCAPE CENTRAL STATION |
| Generic Name | DISPLAY, CATHODE-RAY TUBE, MEDICAL |
| Product Code | DXJ |
| Date Received | 2017-05-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRITIKON DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer Address | CALLE VALLE EL CEDRO 1551 JUAREZ MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-24 |