MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-01-21 for RIFTON 51" SUPINE BOARD E40 manufactured by Rifton Equipment.
[43523]
Source says that child was left unattended in supine board. Another child in the room undid the leg straps, causing child in equipment to get caught in upper strap and lose consciousness as air was cut off. Source alleges that child died a week later as a result of complications related to this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319061-1997-00001 |
| MDR Report Key | 65150 |
| Report Source | 05,06 |
| Date Received | 1997-01-21 |
| Date of Report | 1997-01-18 |
| Date of Event | 1996-10-01 |
| Date Mfgr Received | 1997-01-14 |
| Date Added to Maude | 1997-01-29 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIFTON 51" SUPINE BOARD |
| Generic Name | SUPINE BOARD |
| Product Code | INW |
| Date Received | 1997-01-21 |
| Model Number | E40 |
| Catalog Number | E40 |
| Lot Number | NA |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 65250 |
| Manufacturer | RIFTON EQUIPMENT |
| Manufacturer Address | RT. 213 RIFTON NY 12471 US |
| Baseline Brand Name | RIFTON 51" SUPINE BOARD |
| Baseline Generic Name | 51" SUPINE BOARD |
| Baseline Model No | NA |
| Baseline Catalog No | E40 |
| Baseline ID | * |
| Baseline Device Family | TABLE, MECHANICAL |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K882900 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-01-21 |