MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for R SERIES DEFIBRILLATOR manufactured by Zoll Medical Corporation.
[185718561]
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
[185718562]
Complainant alleged that while attempting to monitor a patient (age & gender unknown), the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable. Complainant indicated that the clinician obtained another device 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
[188145835]
Zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed. The device was put through extensive testing without duplicating the report. The device was able to analyze correctly, and shock appropriately on multiple rhythms without issue with the customer's multifunction cable and a simulator. Without a clinical file. We cannot confirm th results of the patient event. No trend is associated with reports of this type.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2020-00797 |
| MDR Report Key | 9900413 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2020-03-30 |
| 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 | R SERIES DEFIBRILLATOR |
| Generic Name | DEFIBRILLATOR/PACEMAKER |
| Product Code | MKJ |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-18 |
| Model Number | R SERIES |
| Catalog Number | R SERIES |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-30 |