MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for ONESTEP 8900-0224-01 manufactured by Zoll Medical Corporation.
[142879388]
Pads were pulled from supply for the transport defib. They were plugged into defib at that time, but not tested. When rn did quality check on the defib the next day, this set of pads would not work on either the x series or the r series of zoll defibs. The defib would read "short detected" when pads were selected. The monitors displayed poor pad contact. The defib would also not deliver a shock when these pads were plugged in (defib would charge, but nothing would happen when shock button was hit). Manufacturer response for defibrillator pad, (brand not provided) (per site reporter): manufacturer responded by requesting to pull all that lot from service and they will replace it for us.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8543398 |
| MDR Report Key | 8543398 |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-04-22 |
| Report Date | 2019-04-23 |
| Date Reported to FDA | 2019-04-23 |
| Date Reported to Mfgr | 2019-04-24 |
| Date Added to Maude | 2019-04-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) |
| Product Code | MKJ |
| Date Received | 2019-04-24 |
| Catalog Number | 8900-0224-01 |
| Lot Number | 3918 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Manufacturer Address | 269 MILL ROAD CHELMSFORD MA 01824 US 01824 |
| Brand Name | ONESTEP |
| Generic Name | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) |
| Product Code | LIX |
| Date Received | 2019-04-24 |
| Catalog Number | 8900-0224-01 |
| Lot Number | 3918 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Manufacturer Address | 269 MILL ROAD CHELMSFORD MA 01824 US 01824 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-24 |