MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-18 for AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED PADDLES 8011-0139-04 manufactured by Zoll Medical Corporation.
[133482152]
Adult internal defibrillator paddles did not function correctly. The button activation on the handpiece did not work and the set could not be used during cardiac surgery. A second set was obtained. The surgeon cut the cable, so they would not be reprocessed, so testing is hampered. Manufacturer response for autoclavable internal handles with integrated paddles, zoll (per site reporter). They will analyze for reported defects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8260122 |
| MDR Report Key | 8260122 |
| Date Received | 2019-01-18 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-11-12 |
| Report Date | 2019-01-08 |
| Date Reported to FDA | 2019-01-08 |
| Date Reported to Mfgr | 2019-01-18 |
| Date Added to Maude | 2019-01-18 |
| 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 | RISK MANAGER |
| 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 WITH INTEGRATED PADDLES |
| Generic Name | DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) |
| Product Code | LDD |
| Date Received | 2019-01-18 |
| Model Number | 8011-0139-04 |
| Catalog Number | 8011-0139-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Manufacturer Address | 269 MILL RD CHELMSFORD MA 018244105 US 018244105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-01-18 |