MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-08-26 for OLYMPIC COOL-CAP SYSTEM LN401351-505 manufactured by Natus Medical Incorporated.
[53061932]
Event is currently being investigated. Customer stated that there were no issues or problems with the system during treatment. Manufacturing asked if patient expired while being treated, and currently waiting on the user facility to answer. When additional information becomes available, follow-up report will be submitted. No device malfunction reported.
Patient Sequence No: 1, Text Type: N, H10
[53061933]
Customer called asking instructions on how to drain device. Customer stated the a patient was treated with the suspect product. Due to patient medical condition, passed away. Natus technical service inquired if there were any issues/malfunction with device during treatment, customer stated there were no issues.
Patient Sequence No: 1, Text Type: D, B5
[53954166]
Event is currently being investigated. Customer stated that there were no issues or problems with the system during treatment. Manufacturing asked if patient expired while being treated, and currently waiting on the user facility to answer. This is a correction to the initial report. Initial report was labeled as 5 day report due to death of the patient. This report indicates that mdr is changing to 30 day report, as no remedial action is required in this case. When additional information becomes available, follow-up report will be submitted. No device malfunction reported.
Patient Sequence No: 1, Text Type: N, H10
[53954167]
Customer called asking instructions on how to drain device. Customer stated the a patient was treated with the suspect product. Due to patient medical condition, passed away. Natus technical service inquired if there were any issues/malfunction with device during treatment, customer stated there were no issues.
Patient Sequence No: 1, Text Type: D, B5
[56026760]
Natus contacted hospital as a follow up attempt, and (b)(6), rn, who oversaw treatment of the patient, confirmed she had no trouble setting up the device for treatment using the set up wizard. She confirmed there were no contraindications using the cool cap system. She confirmed that there were no alarms or problems with the system during the treatment period (approximately 24 hours) before the patient passed away. She confirmed the patient was diagnosed with cardiac anomalies, chorioamnionitis, and meconium aspiration. Based on the information received from the customer, natus is concluding that device did not malfunction and the patient passed away due to health condition unrelated to device functionality. Natus will continue investigation and attempts to obtain additional information. If additional information becomes available, supplemental follow-up will be submitted. No device malfunction reported.
Patient Sequence No: 1, Text Type: N, H10
[56026761]
Customer called asking instructions on how to drain device. Customer stated the a patient was treated with the suspect product. Due to patient medical condition, passed away. Natus technical service inquired if there were any issues/malfunction with device during treatment, customer stated there were no issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2016-00006 |
| MDR Report Key | 5905570 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-08-26 |
| Date of Report | 2016-08-25 |
| Date Mfgr Received | 2016-08-25 |
| Date Added to Maude | 2016-08-26 |
| 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 | 2016-08-26 |
| Model Number | LN401351-505 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Death | 2016-08-26 |