MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for M SERIES MSERIES BI-PHASIC manufactured by Zoll Medical Corporation.
[127553683]
Zoll medical corporation has received the device and will be providing a supplemental report when our investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[127553684]
Complainant alleged that during biomed testing, the device was unable to obtain an ecg signal via electrode pads. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[128110965]
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed. The device was put through extensive testing which included bench handling and full ecg functionality testing using the returned multifunctional cable without duplicating the malfunction. The device also passed the patient impedence calibration test. The device was recertified and returned to the customer. No trend is associated with reports of this type.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2018-03395 |
| MDR Report Key | 8084166 |
| Date Received | 2018-11-19 |
| Date of Report | 2018-10-29 |
| Date Mfgr Received | 2018-10-29 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2018-11-19 |
| 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 | M SERIES |
| Generic Name | DEFIBRILLATOR/PACEMAKER |
| Product Code | DPS |
| Date Received | 2018-11-19 |
| Returned To Mfg | 2018-11-05 |
| Model Number | MSERIES BI-PHASIC |
| Catalog Number | M SERIES |
| 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 | 2018-11-19 |