MRI CORPORATION N/I M228

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-04 for MRI CORPORATION N/I M228 manufactured by Mri Corporaton.

Event Text Entries

[353] The patient had recently suffered a stroke and seizure prior to being admitted to north valley rehibilitation hospital (nvrh) on 8/4/92. When admitted, the patient appeared to have difficulty both communicating her thoughts and understanding what was said to her and was unable to perform basic daily activities or walk without major assistance. The patient's admitting physician determined that she needed restraints at night until she became oriented to herself and surroundings. On the night of 8/8/92, she was checked and turned at midnight, 1:30 a. M. And at 3:30 a. M. And was found to be sleeping quietly. At 3:00 a. M. The patient received a bolus tube feeding, the patient's vest restraint was adjusted and the patient reporsitioned. At 4:00 a. M. The patient was found slumped over the side of the bed between the rails with the vest restraint intact. She was unresponsive, without respiration. Cpr was performed by the nurse and paramedics until the patient's consulting physician arrived. At 4:20 a. M. Her consulting physician confirmed written "no code order" with the family over the phone. The consulting physician on site gave the order to stop cpr and the patient expired and was pronounced dead at approx. 4:30 a. M. On 8/8/92device not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. 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, visual examination. Results of evaluation: telemetry failure, none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device permanently removed from service, inserviced by other facility staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1360
• MDR Report Key: 1360
• Date Received: 1992-09-04
• Date of Report: 1992-08-25
• Date of Event: 1992-08-08
• Date Facility Aware: 1992-08-08
• Report Date: 1992-08-25
• Date Reported to FDA: 1992-08-25
• Date Reported to Mfgr: 1992-08-25
• Date Added to Maude: 1992-09-23
• 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: MRI CORPORATION
• Generic Name: SLEEVED VEST RESTRAINT W/ZIPPER
• Product Code: BRT
• Date Received: 1992-09-04
• Model Number: N/I
• Catalog Number: M228
• Lot Number: 3165341
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1304
• Manufacturer: MRI CORPORATON

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-09-04