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.
[133482447]
The patient was undergoing cardiac surgery. While coming off bypass the patient went into ventricular fibrillation (v-fib). The internal defibrillator paddles did not work. The activation button on the hand-piece did not work and could not be depressed. There was no clicking of the spring-loaded mechanism under the silicone or rubber(? ) activation button on the hand piece. The operating room team was required to get a second set of defibrillator paddles which took approximately two extra minutes. This same event has happened with two other patients in the last month and in all cases the activation button on the hand-pieces was defective. We have found five defective sets and will be providing some to zoll for testing. We are reviewing our inventory for additional defective hand-pieces. Manufacturer response for autoclavable internal handles with integrated paddles, zoll (per site reporter). They will test sets that we provide.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8260130 |
| MDR Report Key | 8260130 |
| Date Received | 2019-01-18 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-12-29 |
| 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 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Manufacturer Address | 269 MILL RD. CHLEMSFORD MA 018244105 US 018244105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-01-18 |