MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-08 for ASSY,MAIH, 3.0 DIA, W/SWITCH, 100-120VONLY 1011-0139-04 8011-0139-04 manufactured by Zoll Medical Corporation.
[138274300]
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
[138274301]
Complainant alleged that while attempting to treat a patient (age & gender unknown), the internal handles failed to discharge. Complainant indicated that the clinician obtained another set of internal handles to continue treating the patient. Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[145013182]
This supplemental medwatch report is reporting the evaluation of the device. This supplemental medwatch report is also correcting information submitted on the initial medwatch report. Evaluation: the customer was contacted for return of the suspect product. The customer has responded and indicated the product will not be returning to zoll.
Patient Sequence No: 1, Text Type: N, H10
[145013183]
Complainant alleged that while attempting to treat a patient (age & gender unknown), the internal handles failed to discharge. Complainant indicated that the ed team had opened the chest of a trauma patient with multiple gun-shot wounds. The patient was in ventricular fibrillation. Cardiac massage was ongoing, along with massive blood transfusion. Complainant indicated that the clinician obtained another set of internal handles to continue treating the patient. Complainant indicated that the patient subsequently expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220908-2019-00660 |
| MDR Report Key | 8404977 |
| Date Received | 2019-03-08 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-02-15 |
| Date Added to Maude | 2019-03-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 269 MILL ROAD |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal | 01824 |
| Manufacturer Phone | 9784219552 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASSY,MAIH, 3.0 DIA, W/SWITCH, 100-120VONLY |
| Generic Name | INTERNAL PADDLE |
| Product Code | LDD |
| Date Received | 2019-03-08 |
| Model Number | 1011-0139-04 |
| Catalog Number | 8011-0139-04 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Death | 2019-03-08 |