MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-18 for AUTOCLAVABLE INTERNAL HANDLES 8011-0501-01 manufactured by Zoll Medical Corporation.
[130648713]
After cardio pulmonary bypass defibrillation was needed using internal paddles set at 5 joules. There was a delay between pushing the button and delivering joules. The first time nothing was delivered. The button was pushed three more times at 5 joules and only 1 joule was actually delivered. Was in the process of switching to another set of defibrillator handles when the patient converted. Reported issue was investigated, it was determined that the internal paddles were 17 years old and passed its sterilization cycle threshold of 100 sterilizations. Manufacturer response for defibrillator paddles, zoll (per site reporter). Paddles were beyond recommended age. Zoll provided ordering information for new paddles.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8173754 |
| MDR Report Key | 8173754 |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-07-23 |
| Report Date | 2018-12-13 |
| Date Reported to FDA | 2018-12-13 |
| Date Reported to Mfgr | 2018-12-18 |
| Date Added to Maude | 2018-12-18 |
| 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 | 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 | AUTOCLAVABLE INTERNAL HANDLES |
| Generic Name | DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) |
| Product Code | LDD |
| Date Received | 2018-12-18 |
| Catalog Number | 8011-0501-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 17 YR |
| 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 | 2018-12-18 |