MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-05 for ONESTEP 8900-0224-01 manufactured by Zoll Medical Corporation.
[35011379]
Patient Sequence No: 1, Text Type: N, H10
[35011380]
Code blue took place earlier this month. Manager was alerted that while moving the patient the cords pulled out of the pads and they scrambled to get new pads. No harm to patient. There is also a oral report of same type of event occurring in (b)(6) of this year. Unfortunately, neither set of electrodes were saved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5343060 |
| MDR Report Key | 5343060 |
| Date Received | 2016-01-05 |
| Date of Report | 2015-12-17 |
| Date of Event | 2015-12-09 |
| Report Date | 2015-12-17 |
| Date Reported to FDA | 2015-12-17 |
| Date Reported to Mfgr | 2015-12-17 |
| Date Added to Maude | 2016-01-05 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | ONESTEP |
| Generic Name | AID, CARDIOPULMONARY RESUSCITATION |
| Product Code | LIX |
| Date Received | 2016-01-05 |
| Catalog Number | 8900-0224-01 |
| ID Number | CE 0123 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Manufacturer Address | 269 & 271 MILL ROAD CHELMSFORD MA 01824 US 01824 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-05 |