MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-07-09 for MD3A 6940-00-0001-XX manufactured by Datascope Corp..
[120222]
The customer reported that the unit's screen was blank.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2221819-1998-00468 |
| MDR Report Key | 176340 |
| Report Source | 07 |
| Date Received | 1998-07-09 |
| Date of Report | 1998-06-15 |
| Date of Event | 1998-06-15 |
| Date Mfgr Received | 1998-06-15 |
| Date Added to Maude | 1998-07-13 |
| 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 | 0 |
| Reporter Occupation | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MD3A |
| Generic Name | DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 1998-07-09 |
| Model Number | MD3A |
| Catalog Number | 6940-00-0001-XX |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 171453 |
| Manufacturer | DATASCOPE CORP. |
| Manufacturer Address | 580 WINTERS AVE. PARAMUS NJ 07653 US |
| Baseline Brand Name | MD3A |
| Baseline Generic Name | DEFIBRILLATOR |
| Baseline Model No | MD3A |
| Baseline Catalog No | 6940-00-0001-XX |
| Baseline ID | NA |
| Baseline Device Family | MD3A |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K810435 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-07-09 |