MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-27 for COOL CAP, PRODUCT CODE: N/A 401350-503 manufactured by Natus Medical Inc..
[56111639]
Device return is anticipated. A follow-up report will be submitted when additional information is available. Device was requested for investigation.
Patient Sequence No: 1, Text Type: N, H10
[56111640]
The customer reported that while doing treatment on an infant there was too much difference in temperature. No adverse patient harm reported. Device return has been requested for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2016-00021 |
| MDR Report Key | 5982214 |
| Date Received | 2016-09-27 |
| Date of Report | 2016-08-29 |
| Date of Event | 2016-08-23 |
| Date Mfgr Received | 2016-08-29 |
| Device Manufacturer Date | 2009-03-31 |
| Date Added to Maude | 2016-09-27 |
| 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. JIM 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COOL CAP, PRODUCT CODE: |
| Generic Name | COOL-CAP |
| Product Code | MXM |
| Date Received | 2016-09-27 |
| Returned To Mfg | 2016-09-16 |
| Model Number | N/A |
| Catalog Number | 401350-503 |
| Lot Number | 1150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2016-09-27 |