MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for ASSY,AUTOCLVBL,INTERNAL HANDLES 1003-0143-04 manufactured by Zoll Medical Corporation.
[134269217]
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[134269218]
Complainant alleged that while attempting to defibrillate a male patient (age unknown) with a gunshot wound, the associated defibrillator failed to discharge using these internal handles. Complainant indicated that the clinician obtained another set of internal handles to continue treating the patient. Complainant indicated that the patient subsequently expired; however they do not believe this was associated with the handles.
Patient Sequence No: 1, Text Type: D, B5
[138085403]
The device was returned to zoll medical corporation. The internal handles were tested and the reported problem was confirmed. It was observed that the handles were in use for 56 months and have most likely met the life span of 100 autoclave cycles. Communication with the customer indicated that the internal handles were not tested prior to use, following sterization or tracked in terms of the number of cycles they have been exposed to. Information has been communicated to the customer. Analysis of reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2019-00173 |
| MDR Report Key | 8283035 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-12-23 |
| Date Mfgr Received | 2019-01-07 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2019-01-28 |
| 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,AUTOCLVBL,INTERNAL HANDLES |
| Generic Name | AUTOCLAVABLE INTERNAL HANDLES |
| Product Code | LDD |
| Date Received | 2019-01-28 |
| Returned To Mfg | 2019-01-14 |
| Model Number | 1003-0143-04 |
| Catalog Number | 1003-0143-04 |
| Lot Number | NA |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-28 |