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 401701-501 manufactured by Natus Medical Incorporated.
[54406596]
After multiple attempts for additional information, natus was unable to obtain any other details regarding this incident. Customer is not responding to the follow-up attempts. Device is not available for evaluation investigation cannot be performed with the information available to natus. If additional information becomes available and device returned for evaluation and investigation, supplemental report will be submitted. No response from the customer.
Patient Sequence No: 1, Text Type: N, H10
[54406597]
Customer stated that staff reported unit would not cool patient. Customer noted that patient was moved to a different cool-cap system in order to continue treatment. There was no injury. At a later time, for two hours customer was attempting to duplicate issue. Per customer, issue could not be duplicated, and device functioned as expected. After multiple attempts for additional information, natus was unable to obtain any other details regarding this incident.
Patient Sequence No: 1, Text Type: D, B5
[66908123]
Device was evaluated by (b)(4). Specific system parameters (temperatures, trends, alarms, etc. ) and environmental conditions were not provided by the customer. A hospital biomed reportedly ran the unit after the event but could not reproduce the failure, and did not provide any data to (b)(4). Two bench-level checks were done to determine if there was an obvious problem with the cooling system: voltage checks in the cooling unit and a bench-level heat-load test. The voltages driving the cooling elements on the cooling block were nominal, and the system was able to maintain minimum cooling block temperatures with maximum heat load input. These results indicated that the system was not having problems cooling. To check the system over a longer period, the unit was instrumented with thermocouples in the external water line and run on a 72 hour cooling cycle with the cap set point set to 8c, which is the lowest set point and therefore the most challenging condition. Outlet water temperature was recorded and found to be 8c for the whole cycle, indicating again that the system was not having problems cooling. Since unit performance during the prior bench checks appeared normal, an ftp was run on the unit to determine if it was operating fully within specification. The unit passed the ftp, confirming that the system operates within specifications. Additionally, the dh rs were reviewed and nothing out of the ordinary was found that would suggest this unit would not cool adequately. (b)(4) was unable to confirm the failure using information provided by the hospital, and neither (b)(4) nor the hospital bio-technicians were able to duplicate the condition. Additionally, no technical problems were found with the cool-cap unit, as it operates fully within specification.
Patient Sequence No: 1, Text Type: N, H10
[66908124]
Customer stated that staff reported unit would not cool patient. Customer noted that patient was moved to a different cool-cap system in order to continue treatment. There was no injury. At a later time, for two hours customer was attempting to duplicate issue. Per customer, issue could not be duplicated, and device functioned as expected. After multiple attempts for additional information, (b)(4) was unable to obtain any other details regarding this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2016-00011 |
| MDR Report Key | 5941092 |
| Report Source | USER FACILITY |
| Date Received | 2016-09-09 |
| Date of Report | 2015-05-06 |
| Date Mfgr Received | 2015-05-06 |
| Device Manufacturer Date | 2011-03-01 |
| 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 | 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 | 2016-10-06 |
| Model Number | 401701-501 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 5 YR |
| 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 |