CURITY 321 H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-04 for CURITY 321 H manufactured by Kendall.

Event Text Entries

[15254185] Machine was utilized on patient and set for five minute heating period to arm. Several minutes later (greater than five minutes) the nurse returned and the patient complained that the heat was too high. The physician examined and felt the patient received a burn. Nursing assessment was made and it is their opinion that a burn may or may not have occurred due to the fact that a pre-existing injury/infection was already present. The question we have is did the machine only allow five minutes of heat? We have decided to pull the machine from service immediatelydevice not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. 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, performance tests performed. Results of evaluation: telemetry failure, none or unknown. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2784
• MDR Report Key: 2784
• Date Received: 1993-01-04
• Date of Report: 1992-08-03
• Date of Event: 1992-07-24
• Date Facility Aware: 1992-07-24
• Report Date: 1992-08-03
• Date Reported to FDA: 1992-08-03
• Date Reported to Mfgr: 1992-08-03
• Date Added to Maude: 1993-03-27
• 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: CURITY
• Generic Name: WET DRESSING HEATER
• Product Code: HGZ
• Date Received: 1993-01-04
• Model Number: 321 H
• ID Number: 30478
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-AUG-84
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2610
• Manufacturer: KENDALL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-01-04