MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-01-27 for AUTOCLAVABLE INTERNAL HANDLES (MSERIES) 8011-0501-01 8011050101 manufactured by Zoll Medical Corporation.
[176465421]
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
[176465422]
Complainant alleged that during functional testing, these internal handles failed to discharge. Complainant did not indicate that there was any patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[186067368]
The internal handles were returned to zoll medical corporation and the customer's report was not replicated or confirmed. The internal handles passed testing and were able to discharge at all energy levels with no faults found. The internal handles were forwarded to scrap as a precaution. Analysis of reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2020-00079 |
| MDR Report Key | 9633260 |
| Report Source | FOREIGN |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-06 |
| Date Mfgr Received | 2020-01-06 |
| Device Manufacturer Date | 2018-03-01 |
| Date Added to Maude | 2020-01-27 |
| 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 | 2020-01-27 |
| Returned To Mfg | 2020-01-27 |
| 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 | 2020-01-27 |