MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-09-28 for AUTOCLAVABLE INTERNAL HANDLES (MSERIES) 8011-0501-01 8011050101 manufactured by Zoll Medical Corporation.
[122017340]
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
[122017341]
Complainant alleged that during biomed testing, the associated defibrillator's defib output was out of specification using these internal handles. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[128205345]
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. The malfunctions were attributed to the internal handle set. The internal handles were replaced to resolve the malfunction. The shock button was confirmed to be damaged. The handles were scrapped. Analysis of reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10
[128205346]
Complainant alleged that during biomed testing, the associated defibrillator's defib output was out of specification using these internal handles. The complainant indicated that the switch was faulting. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220908-2018-02738 |
| MDR Report Key | 7918272 |
| Report Source | FOREIGN |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-09 |
| Date Mfgr Received | 2018-09-09 |
| Device Manufacturer Date | 2018-01-01 |
| Date Added to Maude | 2018-09-28 |
| 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 | AUTOCLAVABLE INTERNAL HANDLES (MSERIES) |
| Generic Name | INTERNAL PADDLE |
| Product Code | LDD |
| Date Received | 2018-09-28 |
| Returned To Mfg | 2018-10-10 |
| 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 | 2018-09-28 |