QUICK QUANT DENSITOMETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-28 for QUICK QUANT DENSITOMETER manufactured by Helena Laboratories.

Event Text Entries

[2053] Falsely low l/s ratioswere reported from densitometer. The leading digit was dropped i. E. , a result of 12. 1 was reported as 2. 1. After communication with helena labs, a circuit board was installed on 2/28/92 and failed to correct problem. Further communication with company revealed that problem was demonstrated at helena labs and therefore is an inherent defect in the quick quant densitometer. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was multiple patient involvement. Number of patients involved: 2. Device serviced in accordance with service schedule. Date last serviced: 01-aug-91. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, computer hardware performance tests conducted. Results of evaluation: component failure. Conclusion: software/firmware caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3684
• MDR Report Key: 3684
• Date Received: 1992-07-28
• Date of Report: 1992-04-30
• Date of Event: 1992-02-10
• Date Facility Aware: 1992-02-26
• Report Date: 1992-04-30
• Date Reported to Mfgr: 1992-02-27
• Date Added to Maude: 1993-04-30
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: QUICK QUANT DENSITOMETER
• Product Code: DXM
• Date Received: 1992-07-28
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3430
• Manufacturer: HELENA LABORATORIES

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-28