MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-05-17 for M SERIES MSERIES CCT manufactured by Zoll Medical Corporation.
[370499]
The device was returned to zoll for an unrelated issue, and during testing by a zoll medical technican, the device failed to power on. There was no pt involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220908-2005-01034 |
| MDR Report Key | 604876 |
| Report Source | 07 |
| Date Received | 2005-05-17 |
| Date of Report | 2005-04-19 |
| Date Mfgr Received | 2005-04-19 |
| Device Manufacturer Date | 2003-03-01 |
| Date Added to Maude | 2005-05-25 |
| 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 | 0 |
| Manufacturer Contact | PAUL DIAS |
| Manufacturer Street | 269 MILL RD |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal | 01824 |
| Manufacturer Phone | 9784219413 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M SERIES |
| Generic Name | DEFIBRILLATOR/PACEMAKER |
| Product Code | MKT |
| Date Received | 2005-05-17 |
| Returned To Mfg | 2005-04-19 |
| Model Number | MSERIES CCT |
| Catalog Number | M SERIES |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 594663 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Manufacturer Address | * CHELMSFORD MA * US |
| Baseline Brand Name | M SERIES |
| Baseline Generic Name | * |
| Baseline Model No | MSERIES CCT |
| Baseline Catalog No | M SERIES CCT |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-05-17 |