MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-10-27 for COOL-CAP 401701-501 manufactured by Natus Medical Inc.
[58598312]
(b)(4). (b)(4) will continue to update the complaint as necessary with additional information when it's available. Conclusion, based on information collected form the customer regarding described event, (b)(4) is concluding that a patients death resulted from patient's underlying condition and was not related to functionality of natus cool-cap system. Not requested, no malfunction.
Patient Sequence No: 1, Text Type: N, H10
[58598313]
It was reported by the customer that low rectal alarm was received as a result of patient's temperature dropping below recommended range. Based on the communication between technical service and customer, the olympic cool-cap system operated per specifications triggering the a15 alarm for very low rectal temperature when the rectal temperature dropped below recommended temperature range of 34. 5? 0. 5? C. There were multiple calls made between technical service and the customer as part of troubleshooting to bring the temperature within recommended range. Technician noted that while talking to a customer, it was mentioned that the patient was a home birth delivery gone terribly wrong. The patient did not receive any medical attention for at least? Hour. Also, during the call the customer confirmed that there was no malfunction of the cool cap system. The actions suggested by technical service and taken by the facility to increase the rectal temperature from 32. 9? C to the recommended range of 34. 5? 0. 5? C followed the action plan documented in troubleshooting guide for a cool-cap system. During approximately two hours of communication between the customer and technical service representative, the rectal temperature increased from 32. 9? C to above 34. 1? C. During the last call to follow-up on the patient status, customer stated that the patient passed away, and that patient's rectal temp prior to passing was still in target range of 34. 3? C. Based on the information received from the customer, there's no indication that olympic cool-cap system malfunctioned. (b)(4) made multiple contact attempts in order to obtain additional information pertaining to reported event, device information and patient's diagnosis and treatment history. As of (b)(6) 2016, there have been no updates from the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2016-00024 |
| MDR Report Key | 6062128 |
| Report Source | USER FACILITY |
| Date Received | 2016-10-27 |
| Date of Report | 2016-10-17 |
| Date of Event | 2016-10-17 |
| Date Mfgr Received | 2016-10-17 |
| Device Manufacturer Date | 2009-09-18 |
| Date Added to Maude | 2016-10-27 |
| 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 | MS. 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOL-CAP |
| Generic Name | COOL-CAP |
| Product Code | MXM |
| Date Received | 2016-10-27 |
| Model Number | 401701-501 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-10-27 |