MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2002-04-02 for PRESTO FLASH SPIROMETER (FORMERLY PRESTO DIAGNOSTIC SPIROMET 100356 NA manufactured by Spacelabs Burdick, Inc..
[21705473]
The presto flash spirometer may include a 930c or 940c deskject printer which can be ordered from spacelabs burdick as an option to the system. Longwell electronics and hewlett-packard is recalling ac power cords shipped with certain inkjet printers mfg by hewlett-packard. The plug that connects the power cord to the printer may crack, exposing live electrical contacts and presenting a hazard for electric shock or electrocution. The recall is isolated to longwell "ls7c" gray two pring power cords. The cords were shipped with certain hp deskjet and photosmart printers in the u. S. And canada from april 2001 through 2002. Printers that may be affected are the hp deskjet 800 series and 900 series, hp photosmart 1000 series, 1100 series, 1200 series and 1300 series. Hp's engineers discovered this potential defect during routine returns to their company's repair center. Hp has not received any complaints from customers that have experienced this issue. There have been no reports of injury. Longwell electronics and hewlett-packard's web site provides instructions to identify the suspect power cord and a phone number for ordering a replacement power cord.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112020-2002-00002 |
| MDR Report Key | 387281 |
| Report Source | 07,08 |
| Date Received | 2002-04-02 |
| Date of Report | 2002-04-01 |
| Date Mfgr Received | 2002-03-08 |
| Date Added to Maude | 2002-04-11 |
| 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 | 0 |
| Manufacturer Contact | SUSAN JOHNSON |
| Manufacturer Street | 500 BURDICK PKWY |
| Manufacturer City | DEERFIELD WI 53531 |
| Manufacturer Country | US |
| Manufacturer Postal | 53531 |
| Manufacturer Phone | 8007771777 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESTO FLASH SPIROMETER (FORMERLY PRESTO DIAGNOSTIC SPIROMET |
| Generic Name | SPIROMETER |
| Product Code | BZG |
| Date Received | 2002-04-02 |
| Model Number | 100356 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 376299 |
| Manufacturer | SPACELABS BURDICK, INC. |
| Manufacturer Address | 500 BURDICK PARKWAY DEERFIELD WI 53531 US |
| Baseline Brand Name | PRESTO FLASH SPIROMETER |
| Baseline Generic Name | SPIROMETER |
| Baseline Model No | 100356 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | PRESTO FLASH SPIROMETER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K894997 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-04-02 |