MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-09-09 for OLYMPIC COOL-CAP SYSTEM 401351-501 manufactured by Natus Medical Incorporated.
[54408012]
Device has been returned to natus, and currently pending evaluation and investigation. When investigation is complete, and root cause determined, supplemental mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[54408013]
Customer stated that system froze on a blank screen and prompted "operating system not found". Upon reboot, the system function returned. Customer confirmed that the system clock was advancing and water was cool to the touch. Cathy (customer) from the nicu followed up with natus and confirmed that the system was functioning fine. All information remained after the reboot, and the patient's rectal temp was within target range. No injury.
Patient Sequence No: 1, Text Type: D, B5
[66706179]
Device was returned and evaluated. The first objective was to determine if the failure condition existed in the unit as-received, and if not, to see if it could be duplicated. The unit was turned on and it booted to the home screen normally. It was then run for 10 days, at which point a black screen failure occurred with the "operating system not found" message displayed. The alarm in the cooling module was beeping indicating that cooling had stopped. This event duplicated one of the failures reported by the hospital. The "operating system not found" error message is generated by the bios during the start-up sequence when the hard drive is actually missing, data is unusable, or it can't find the mbr. A compromised hard drive can result in the immediate reboot of the system. This has also been observed on lab units. This type of error is not uncommon in pc architecture-based systems, like the cool-cap system. The operating system is located on the hard drive, so if the hard drive is compromised, the system will fail to operate correctly. Because of the affinity towards a hard drive error in this unit, further tests were focused on hard drive integrity. The customer indicated that the unit worked properly after rebooting the system after the failure occurred. System logs indicate that it had been used several times between and after the reported failures. The unit ran 10 days at natus before the error occurred. Given these three scenarios, it can be concluded that the loss of the os is intermittent, and doesn't necessarily have a direct stimulus (such as an extreme environment, movement, etc). The black screen failure occurred twice at the hospital, and once at natus. All cases can be characterized as intermittent failures without a specific stimulus. Since the failure cannot be reproduced on demand, the exact root cause cannot be determined. However, the loss of the operating system is necessarily a result of compromised data from the hard drive. The most likely root cause is a failing hard drive or a failing ide cable, likely due to component age.
Patient Sequence No: 1, Text Type: N, H10
[66706180]
Customer stated that system froze on a blank screen and prompted "operating system not found". Upon reboot, the system function returned. Customer confirmed that the system clock was advancing and water was cool to the touch. Cathy (customer) from the nicu followed up with natus and confirmed that the system was functioning fine. All information remained after the reboot, and the patient's rectal temp was within target range. No injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2016-00012 |
| MDR Report Key | 5941081 |
| Report Source | USER FACILITY |
| Date Received | 2016-09-09 |
| Date of Report | 2015-12-16 |
| Date Mfgr Received | 2015-12-16 |
| Device Manufacturer Date | 2008-03-21 |
| 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 | SVETLANA ROMANETS |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685170 |
| 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 |
| Remedial Action | OT |
| 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 | 2016-08-29 |
| Model Number | 401351-501 |
| 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 |