MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-03-09 for MD3A 6940-00-0001-XX manufactured by Datascope Corp..
[17437573]
The customer reported that when the unit was put into use on a pt, the unit emitted a "pop" noise and would no longer charge. Another unit was used on the pt. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2221819-1999-00101 |
MDR Report Key | 214326 |
Report Source | 07 |
Date Received | 1999-03-09 |
Date of Report | 1999-01-28 |
Date of Event | 1999-01-28 |
Date Mfgr Received | 1999-01-28 |
Date Added to Maude | 1999-03-18 |
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 |
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 | 1999-03-09 |
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 | 207904 |
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 | 1999-03-09 |