MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-20 for ZOLL 8900-0224-01 manufactured by Zoll Medical Corp..
[50463083]
A patient suffered a cardiac arrest requiring defibrillation. The zoll onestep cpr complete pad had poor adherence to the patient's chest wall, even after the chest hair was shaved/removed. Remaining product from the lot number was checked and additional pads were found to be less sticky or adherent than other lots in stock. A second lot number was also found to be deficient in adherence. Both lots were removed from emergency/crash carts and replaced with effective product.
Patient Sequence No: 1, Text Type: D, B5
[50532128]
Additional information received on 07/20/2016 from report or report # mw5063598: this medwatch report follows a prior report outlining issues with the adhesive properties of the zoll onestep cpr complete electrodes. Prior defective lot # reported were 2016c and 1816. Six boxes of replacement product received from (b)(4) is also defective, lacking adequate adhesive to adhere to a patient's skin. Zoll has been notified and we are expecting an overnight shipment from the company to be available on 07/21/2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063598 |
| MDR Report Key | 5818657 |
| Date Received | 2016-07-20 |
| Date of Report | 2016-07-20 |
| Date of Event | 2016-07-20 |
| Date Added to Maude | 2016-07-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | ZOLL |
| Generic Name | ONESTEP CPR COMPLETE ELECTRODES |
| Product Code | LIX |
| Date Received | 2016-07-20 |
| Catalog Number | 8900-0224-01 |
| Lot Number | 2016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORP. |
| Manufacturer Address | 269 MILL RD. CHELMSFORD MA 018244015 US 018244015 |
| Brand Name | ZOLL |
| Generic Name | ONESTEP CPR COMPLETE ELECTRODES |
| Product Code | LIX |
| Date Received | 2016-07-20 |
| Catalog Number | 8900-0224-01 |
| Lot Number | 2116 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORP. |
| Manufacturer Address | 269 MILL RD. CHELMSFORD MA 018244015 US 018244015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-20 |