MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-02-06 for ECHO-SCREEN II 5-KEY 1089 manufactured by Natus Europe Gmbh.
[135191688]
The suspected product was requested back to natus for evaluation. Investigation done by natus europe: chargers are operating due to spec. Polarity of charger plug checked. The exploded battery cell bears soot and is torn open at the top (positive pole). The battery housing is melted. Four remaining cells do not show visible damage. Pepi mode switch does not show visible damage. The root cause of the incident: apparently one cell of the battery (the only one which lies horizontal in the housing) got shorted and therefore overheated which led to the explosion. The pepi mod safety switch and the remaining four cells appear still operational. No initial corrective/preventive actions implemented by the manufacturer at this time. If additional information becomes available natus will file a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[135191689]
Customer reported that during charging of the battery the battery exploded pn#1089. The event occured during a time when the room was not occupied by anybody; however, the carpets caught fire and the fire brigade was called to extinguish the fire. The battery was disconnected from the mains by personnel before the fire fighters arrived. The customer did not report patient involvement, serious injury or delay in treatment and nobody was hurt during the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2019-00001 |
| MDR Report Key | 8311259 |
| Report Source | USER FACILITY |
| Date Received | 2019-02-06 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-09-25 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2005-09-04 |
| Date Added to Maude | 2019-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685173 |
| Manufacturer G1 | NATUS EUROPE GMBH |
| Manufacturer Street | ROBERT-KOCH-STR. 1 |
| Manufacturer City | PLANEGG, GERMANY 82152 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 82152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECHO-SCREEN II 5-KEY |
| Generic Name | ECHO-SCREEN II |
| Product Code | GWJ |
| Date Received | 2019-02-06 |
| Model Number | 1089 |
| Lot Number | 040905 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS EUROPE GMBH |
| Manufacturer Address | ROBERT-KOCH-STR. 1 PLANEGG GERMANY 82152 GM 82152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-06 |