MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-10-26 for BONE DENSITOMETER QDR 1000 * manufactured by Hologic, Inc..
[542076]
As reported by the facility: patient sat on a bone density table. Rivets on the plexiglass frame broke, plexiglass fell into table leaving a hole under pt as she lay supine on the table.
Patient Sequence No: 1, Text Type: D, B5
[8058852]
On 09/20/06 the hosp rep called hologic customer serivce, reporting that the listed device malfunctioned and requested info concerning the weight limit on the table. Hologic provided the weight limit (300 ibs) and dispatched field engineers who contacted the hosp to schedule a visit. At that point the hosp rep declined service and indicated that the device has been removed from use. The rep also provided info that indicated that the device was repaired in the past not in accordance with the mfr specification. The repair involved the use of unauthorized hardware to repair the device at some point in the past. The repair was directly in the area that was involved in the incident described in this report. Any previous problems with the device were not reported to hologic. Hologic did not service this equipment during the 15 years this device was in use. Hologic concluded, that the failure occurred due to the use of the unauthorized and unverified hardware (rivets) that was used to support the plexiglass section of the table.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221300-2006-00004 |
| MDR Report Key | 796020 |
| Report Source | 05,06 |
| Date Received | 2006-10-26 |
| Date of Report | 2006-10-20 |
| Date of Event | 2006-09-20 |
| Date Added to Maude | 2006-12-20 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ARTHUR FRIEDMAN, VP |
| Manufacturer Street | 35 CROSBY DR |
| Manufacturer City | BEDFORD MA 01730 |
| Manufacturer Country | US |
| Manufacturer Postal | 01730 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE DENSITOMETER |
| Generic Name | BONE DENSITOMETER, TABLE |
| Product Code | KGI |
| Date Received | 2006-10-26 |
| Model Number | QDR 1000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 754876 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | * BEDFORD MA 01730 US |
| Baseline Brand Name | BONE DENSITOMETER |
| Baseline Generic Name | BONE DENSITOMETER, TABLE |
| Baseline Model No | QDR 1000 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-26 |