MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-12-30 for X SERIES manufactured by Zoll Medical Corporation.
[173281081]
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
[173281082]
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown)in cardiac arrest, the ecg signal was delayed approximately 30 seconds after the third shock was administered to the patient, after the patient was in rosc. 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
[184967035]
The device was not returned to zoll medical corporation for evaluation. Instead, the device data file was provided for review. However, the data file was from an event that occurred on (b)(6)2019 only showed that a single shock was performed. The data file does not appear to be from the reported event. Without the device or the data from the reported event, we are unable to investigate any further. The data file evaluation revealed no device errors that would have prevented the ecg data from displaying. No trend is associated with reports of this type.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2019-04006 |
| MDR Report Key | 9531870 |
| Report Source | FOREIGN |
| Date Received | 2019-12-30 |
| Date of Report | 2019-12-09 |
| Date Mfgr Received | 2019-12-09 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2019-12-30 |
| 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 | X SERIES |
| Generic Name | DEFIBRILLATOR/PACEMAKER |
| Product Code | DRT |
| Date Received | 2019-12-30 |
| Model Number | X SERIES |
| Catalog Number | X SERIES |
| Lot Number | NA |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-12-30 |