MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-31 for ASSY,M AIH, 1.6 DIA, W/SWITCH, 100-120V ONLY 1011-0139-02 manufactured by Zoll Medical Corporation.
[134628147]
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
[134628148]
Complainant alleged that during biomed testing, the associated defibrillator failed to discharge using these attached internal handles. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[140306938]
This supplemental medwatch report is reporting the evaluation of the device. This supplemental medwatch report is also updating information submitted on the initial medwatch report. Evaluation results: the internal handles were received for evaluation with the paddle wires cut through on the shock button side. The shock button was observed stuck in place and unable to move. Due to the damage, the internal handles were unable to be tested for discharge functionality. After dissection/disassembly of the handles we were able to confirm that the internal components had migrated to a void inside the handle cavity causing the shock button not to function. It was determined that extreme heat of 400 degrees or more would be required to cause the observed internal components migration well outside recommended temperature exposure for the handles. The cause of the exposure could not be firmly established with the end user. However, this circumstance appears to be isolated to this facility. Analysis of reports of this type has not identified an increase in trend.
Patient Sequence No: 1, Text Type: N, H10
[140306939]
Complainant alleged that while attempting to treat a (b)(6) year old male patient, the associated defibrillator failed to discharge using these attached internal handles. Complainant indicated that the clinician obtained another set of handles to continue treating the patient. Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220908-2019-00193 |
| MDR Report Key | 8293754 |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-10 |
| Date Mfgr Received | 2019-01-10 |
| Device Manufacturer Date | 2016-11-01 |
| Date Added to Maude | 2019-01-31 |
| 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,M AIH, 1.6 DIA, W/SWITCH, 100-120V ONLY |
| Generic Name | INTERNAL HANDLE |
| Product Code | LDD |
| Date Received | 2019-01-31 |
| Returned To Mfg | 2019-01-30 |
| Model Number | 1011-0139-02 |
| Catalog Number | 1011-0139-02 |
| 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 | 2019-01-31 |