MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for X SERIES manufactured by Zoll Medical Corporation.
[185718285]
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
[185718286]
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown) in cardiac arrest, after the first shock at 200 joules, the device self-selected the energy level of 120 joules and the shock was delivered. Complainant indicated that the clinician obtained another device 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
[187162833]
Zoll medical corporation evaluated the device and the device performed to specification. The device was put through extensive testing including full stress and functionality testing, discharge testing and defib cycle testing without duplicating the report. The device was recertified and returned to the customer. Review of the device activity logs showed evidence of a 200 joule shock being delivered and a 120 joule shock entry with 141 joules of energy delivered. Based on the impedance of 57 ohms, this shock was within device specifications. The logs did not find any evidence to support the device auto changing the energy. The battery involved and accessories were not available as part of this investigation. No trend is associated with reports of this type.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2020-00819 |
| MDR Report Key | 9900399 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2013-08-01 |
| 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 | X SERIES |
| Generic Name | DEFIBRILLATOR/PACEMAKER |
| Product Code | MKJ |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-12 |
| Model Number | X SERIES |
| Catalog Number | X 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 |