FLUOROBED 27HEFW00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-01 for FLUOROBED 27HEFW00 manufactured by Hausted Critical Care.

Event Text Entries

[607] On 5/28/92, a pt in the icu recuperating from gastric surgery, became wedged in the raised side rail of the hausted critical care fluorobed. The pt was at waist leve with his legs almost to the floor, his airway was not obstructed by the bed rail. He was found unresponsive, pulseless, no audible bp, cardiac monitor showed a heart rate of 38 and agonal respirations were noted. With some difficulty the patient was dislodged from the side rail and resuscitated. At this time, gastric contents were suctioned from the patient's mouth and nose. Due to the patient's age and terminal condition, the family refused further resusitation, the patient expired two hours laterdevice not labeled for single use. Patient medical status prior to event: critical 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. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. 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: 1085
• MDR Report Key: 1085
• Date Received: 1992-07-01
• Date of Report: 1992-06-24
• Date of Event: 1992-05-28
• Date Facility Aware: 1992-06-02
• Report Date: 1992-06-24
• Date Reported to FDA: 1992-06-24
• Date Reported to Mfgr: 1992-06-24
• Date Added to Maude: 1992-08-20
• 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: FLUOROBED
• Generic Name: HOSPITAL BED
• Product Code: FNK
• Date Received: 1992-07-01
• Model Number: 27HEFW00
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1039
• Manufacturer: HAUSTED CRITICAL CARE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-07-01