ADAMCO SAFETY VEST 26-0033

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-05-10 for ADAMCO SAFETY VEST 26-0033 manufactured by E.m. Adams Company, Inc..

Event Text Entries

[3804] Patient admitted wit shortness of breath. Patient had a history of carcinoma of the lungs with metastasis to the liver. Had previously received both chemotherapy and radiation. On rounds, nurse found patient with upper body caught between upper and lower siderail. Left arm was caught in the rail, face laying against the upper siderail, buttocks and legs resting on floor. Safety vest still attached to patient with straps attached to bed. Patient was not brething. Patient expired. Cause of death listed as pneumonia and carcinoma of the lunginvalid data - regarding single use labeling of device. 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 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: unknown (cannot determine). Corrective actions: 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: 1054786-1992-00006
• MDR Report Key: 6095
• Date Received: 1993-05-10
• Date of Report: 1993-02-26
• Date of Event: 1992-11-07
• Date Facility Aware: 1992-11-07
• Report Date: 1993-02-26
• Date Reported to FDA: 1993-02-26
• Date Reported to Mfgr: 1993-02-26
• Date Added to Maude: 1993-08-05
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• 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: ADAMCO SAFETY VEST
• Generic Name: PATIENT BODY RESTRAINT
• Product Code: KID
• Date Received: 1993-05-10
• Model Number: 26-0033
• Operator: OTHER
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5787
• Manufacturer: E.M. ADAMS COMPANY, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-05-10