MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for AUTOCLAVABLE INTERNAL HANDLES 8011-0501-01 8011050101 manufactured by Zoll Medical Corporation.
[126080337]
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
[126080338]
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown) during an open heart surgery, the associated defibrillator failed to discharge using these internal handles. Complainant indicated that the clinician obtained another pair 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
[130987494]
The internal handles were returned to zoll medical corporation for evaluation. The reported malfunction was observed intermittently during initial evaluation. However, additional testing, which included shock testing at various joule settings, cable stressing and manipulation but the signal remained constant. The internal handles passed all tests. The internal handles were scrapped. Analysis of reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2018-03196 |
| MDR Report Key | 8037218 |
| Date Received | 2018-11-05 |
| Date of Report | 2018-10-15 |
| Date Mfgr Received | 2018-10-15 |
| Device Manufacturer Date | 2018-05-01 |
| Date Added to Maude | 2018-11-05 |
| 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 |
| Generic Name | INTERNAL PADDLE |
| Product Code | LDD |
| Date Received | 2018-11-05 |
| Returned To Mfg | 2018-11-28 |
| 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 | 2018-11-05 |