MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-12 for CARESCAPE PRO CLINICAL INFORMATION CENTER (CIC) MP100D 2037318-003F manufactured by Ge Medical Systems Information Technologies.
[5805031]
A telemetry patient continued to experience leads off without re-notification to the team. A leads failed was sent at ~1601 but never again. The leads had been replaced by the rn at around 1900. The patient was found at 2025 non-responsive but a leads failed alarm was never sent again (last one being ~1601). When the patient was found, the leads were off of the body. In addition, the ascom system went down and was not sending alarms to the pct (patient care technician) phones. According to the cic (clinical information center) log there were no alarms that were appearing on the cic as indicated on the log. (cic had the ability to be disabled). We cannot say for certain if after the leads were replaced another alarm went to the sands portable telephone device to indicate a leads off alarm or any other alarm. Sands devices did not have a built in escalation for "technical alarms". Another concern is that when an alarm is silenced at the cic it silences all alarms--this should not be an option. Silencing one alarm should only allow you to silence that alarm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4773800 |
| MDR Report Key | 4773800 |
| Date Received | 2015-05-12 |
| Date of Report | 2015-04-27 |
| Date of Event | 2015-04-06 |
| Report Date | 2015-04-27 |
| Date Reported to FDA | 2015-05-12 |
| Date Reported to Mfgr | 2015-05-15 |
| Date Added to Maude | 2015-05-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARESCAPE PRO CLINICAL INFORMATION CENTER (CIC) |
| Generic Name | DETECTOR AND ALARM, ARRHYTHMIA |
| Product Code | MSX |
| Date Received | 2015-05-12 |
| Model Number | MP100D |
| Catalog Number | 2037318-003F |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| Manufacturer Address | 8200 WEST TOWER AVENUE MILWAUKEE WI 53223 US 53223 |
| Brand Name | TELLIGENCE; UNITE CONNECT FOR NURSE CALL |
| Generic Name | SYSTEM, ENVIRONMENTAL CONTROL, POWERED |
| Product Code | IQA |
| Date Received | 2015-05-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| Manufacturer Address | 8200 WEST TOWER AVENUE MILWAUKEE FL 53223 US 53223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-05-12 |