MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-09 for OLYMPIC COOL-CAP SYSTEM 401351-505 manufactured by Natus Medical Incorporated.
[54781630]
Device return is anticipated. A follow-up report will be submitted when additional information is available.
Patient Sequence No: 1, Text Type: N, H10
[54781631]
Customer called natus on (b)(6) 2016 stating that cool-cap device screen "shut down" and would not respond to any action. Natus contacted customer for additional information that would assist in making reportability decision, and on (b)(6) 2016, customer responded with a statement that device experienced a screen freeze with time clock stopping and no alarm was noted by the nurse. Customer was able to get the system started again after about 30 minutes and they did complete the treatment of the patient. There was no injury.
Patient Sequence No: 1, Text Type: D, B5
[68476645]
The device was returned and evaluated. The system log indicates the device was functioning as intended and was delivering continuous therapy to the patient when the screen was frozen. Cooling sessions with a data capture system were ran for 720 hours without having any freeze events. The watchdog hardware was tested and demonstrated that the watchdog system was functioning correctly. A functional test procedure was performed and all items regarding the reported event passed. The system also reacted appropriately when temperature dropped below the lower control band and initiated alarm. The audible alarm and display circuitry are independent of each other, so it's probable that an audible alarm did occur. (b)(4) was unable to confirm the failure using information provided by the hospital, session data analysis, testing, or by direct or indirect observation of the failure. The failure was not duplicated throughout all testing. Additionally, no functional or performance problems were found with the cool-cap unit, as it operates fully within specification. Root cause cannot be determined. The device malfunction was found to be isolated to the display and the device continued to deliver the therapeutic cooling function, with exception for the time periods when the system was rebooting.
Patient Sequence No: 1, Text Type: N, H10
[68476646]
Customer called (b)(4) on (b)(6) 2016 stating that cool-cap device screen "shut down" and would not respond to any action. (b)(4) contacted customer for additional information that would assist in making reportability decision, and on (b)(6) 2016, customer responded with a statement that device experienced a screen freeze with time clock stopping and no alarm was noted by the nurse. Customer was able to get the system started again after about 30 minutes and they did complete the treatment of the patient. There was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2016-00014 |
| MDR Report Key | 5941082 |
| Date Received | 2016-09-09 |
| Date of Report | 2016-04-18 |
| Date Mfgr Received | 2016-04-18 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2016-09-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEFFREY MANTKOWSKI |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685143 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC COOL-CAP SYSTEM |
| Generic Name | COOL CAP |
| Product Code | MXM |
| Date Received | 2016-09-09 |
| Returned To Mfg | 2016-09-09 |
| Model Number | 401351-505 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-09 |