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 2011-12-07 for EMBLA S7000 2000202 manufactured by Embla Systems, Inc..
[15579378]
During a sleep study for a (b)(6) child, the nurse's station was alerted that the device had become disconnected. When the nurse went to check on the pt, she found that the lead cable attached to the embla wall unit was wrapped tightly around the pt's neck twice. The pt was very restless during the night and nursing staff had entered the room regularly to adjust the pulse oximeter probe. No injury and pt was assessed and observations were within normal limits for age of child. Extra observation of pt by nursing.
Patient Sequence No: 1, Text Type: D, B5
[15943838]
There are always typical risks associated with any cabled device when in use with pediatric pts. Due to this risk, embla had added a cautionary statement to the instructions for use for the embla s7000 device. Cautionary statement reads, "caution must be taken to ensure that cables do not encircle the pt's neck. Special attention is needed in the case of children. " as add'l mitigation, embla designed the sys inter-component cables with tamper proof screw-in connectors which are to be secured by the end user during installation. It could not be determined by the customer event report, or by further questioning, how the cable became disconnected, or if it had been properly secured prior to the sleep study in question. Advised health care facility of the warnings and cautionary statements within the instructions for use for the embla s7000 device when working with pediatric pts and requested further info on the event. Health care facility was unable to provide any further details and the device was not returned. Determination of abnormal use based on incident report from health care facility. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005844579-2011-00001 |
| MDR Report Key | 2366289 |
| Report Source | 01,05,06 |
| Date Received | 2011-12-07 |
| Date of Report | 2011-12-01 |
| Date of Event | 2011-09-01 |
| Date Mfgr Received | 2011-11-12 |
| Date Added to Maude | 2012-07-23 |
| 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 | 3 |
| Manufacturer Street | 9351 GRANT ST STE 600 |
| Manufacturer City | THORNTON CO 80229 |
| Manufacturer Country | US |
| Manufacturer Postal | 80229 |
| Manufacturer Phone | 3039621800 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBLA S7000 |
| Generic Name | S7000 BEDSIDE UNIT |
| Product Code | MNR |
| Date Received | 2011-12-07 |
| Model Number | S7000 |
| Catalog Number | 2000202 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMBLA SYSTEMS, INC. |
| Manufacturer Address | 9351 GRANT ST, STE 600 THRONTON CO 80229 US 80229 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2011-12-07 |