MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-02 for THERMOGARD XP? manufactured by Zoll Circulation, Inc..
[181567793]
The nurse noted that the device was making a clicking noise, however, all components of the device were still in working order. The resource nurse also observed the device and noted a clicking noise, but no faults were found with the device at that time. An hour later the nurse entered the room to find the 500 ml saline bag empty and the saline solution leaked onto the floor. The device appeared to still be working with no warning notice seen. The patient was assessed and found to be stable with no evidence of harm related to the device malfunction. The nurse inspected the device by lifting up the hood and the roller clamp lid of the device for assessment of the tubing. At that time, a warning message appeared stating, "air trap fault, check saline level. " the resource nurse was called in and found that the tubing was punctured by a jagged white plastic roller clamp prong. All of the equipment was sequestered. A new set/machine was reattached to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9774191 |
| MDR Report Key | 9774191 |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-04 |
| Report Date | 2020-02-24 |
| Date Reported to FDA | 2020-02-24 |
| Date Reported to Mfgr | 2020-02-28 |
| Date Added to Maude | 2020-03-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOGARD XP? |
| Generic Name | SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING |
| Product Code | NCX |
| Date Received | 2020-03-02 |
| Model Number | THERMOGARD XP |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL CIRCULATION, INC. |
| Manufacturer Address | 2000 RINGWOOD AVE SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |