MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-01 for OLYMPIC COOL-CAP 401351-505 manufactured by Natus Medical Incorporated.
[115776322]
The cool-cap system was returned to natus for evaluation. Natus factory service found that a cooling module inside the cooling block was operating out of specification. Both cooling modules were replaced and the repaired cool-cap system was returned to the user facility. The complainant reported that the repaired cool-cap system passed their initial testing. No further communication was received.
Patient Sequence No: 1, Text Type: N, H10
[115776323]
It was reported to natus that a cool-cap system was not cooling quickly enough when the cap temperature was set to 8 degrees c. The temperature remained at 14 degrees c three hours after setting the cap temperature to 8 degrees c. A patient was being treated with the system when the event occurred. The patient was immediately moved to another cool-cap system. The cool-cap system involved in the event was taken out of service. There was no report of death, serious injury, or environmental/safety concerns. The biomed at the user facility who reported the event did not witness the event and could not provide any additional details. Temperature data could not be retrieved because the system had been rebooted. The biomed tested the system's performance immediately after the event. The patient weight was selected as (b)(6) and the gestational age was selected as 36 weeks which prompted the cap temperature to 23. 1 degrees c. After an initial cooling period the biomed set the cap temperature to 12 degrees c. The biomed stated that it took about an hour for the cap temperature to reach 12 degrees c. Natus technical service asked the biomed to set the cap temperature to 15 degrees c, and within 8 minutes the cap temperature reached 14. 7 degrees c.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00136 |
| MDR Report Key | 7740215 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-01 |
| Date of Report | 2017-01-19 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-01-19 |
| Date Added to Maude | 2018-08-01 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 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 | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC COOL-CAP |
| Generic Name | COOL-CAP |
| Product Code | MXM |
| Date Received | 2018-08-01 |
| Returned To Mfg | 2017-02-13 |
| Model Number | 401351-505 |
| Device Availability | R |
| 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 | 2018-08-01 |