R.G.M. 5250 6051-0000-012

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-17 for R.G.M. 5250 6051-0000-012 manufactured by Ohmeda.

Event Text Entries

[1388] Each rgm receives an annual preventive maintenance (pm) inspection. Among other parts replaced during this pm a new pueumatic assembly is installed. In two (2) seperate parts orders a total of 10 assemblies were ordered. Out of these 10, 6 had pumps that would not start and another pump started but leaked. Ohmeda replaced all seven and some of the replacements also would not start the pump. These also were replaceddevice not labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-oct-92. 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: electrical tests performed, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: electrical problem, inadequate quality assurance. Conclusion: device failed during assembly, device failed just prior to use, device was out of calibration. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1822
• MDR Report Key: 1822
• Date Received: 1992-11-17
• Date of Report: 1992-10-29
• Date of Event: 1992-09-22
• Date Facility Aware: 1992-09-22
• Report Date: 1992-10-29
• Date Reported to FDA: 1992-10-29
• Date Reported to Mfgr: 1992-10-01
• Date Added to Maude: 1992-12-04
• 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: R.G.M.
• Generic Name: RESPIRATORY GAS MONITOR WITH AGENT
• Product Code: LPP
• Date Received: 1992-11-17
• Model Number: 5250
• Catalog Number: 6051-0000-012
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1699
• Manufacturer: OHMEDA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-11-17