MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-11 for AUTOCLAVABLE INTERNAL HANDLES (MSERIES) 8011-0501-01 8011050101 manufactured by Zoll Medical Corporation.
[138432191]
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
[138432192]
Complainant alleged that during biomed testing, the associated defibrillator failed leakage current test using these internal handles. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[139553956]
The internal handles were returned to zoll medical corporation and the customer's report was not replicated or confirmed. The internal handles were put through extensive testing including full functionality testing multiple discharges and leakage testing without duplicating the report. The internal handles were returned to the customer. No trend is associated with reports of this type.
Patient Sequence No: 1, Text Type: N, H10
[145780603]
After further investigation it was determined that the cause of the problem was due to a test set up configuration and was not due to a malfunction of the device. Analysis of reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2019-00584 |
| MDR Report Key | 8409247 |
| Date Received | 2019-03-11 |
| Date of Report | 2019-02-18 |
| Date Mfgr Received | 2019-02-18 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2019-03-11 |
| 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 | AUTOCLAVABLE INTERNAL HANDLES (MSERIES) |
| Generic Name | INTERNAL PADDLE |
| Product Code | LDD |
| Date Received | 2019-03-11 |
| Returned To Mfg | 2019-02-26 |
| Model Number | 8011-0501-01 |
| Catalog Number | 8011050101 |
| 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 | 2019-03-11 |