MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; GOWN, PATIENT

Catalog Number MDTPG5RTSDEMZ

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 08/28/2016

Event Type  Death  

Manufacturer Narrative

Per director of nursing (don) at facility who stated on (b)(6) nursing staff found a patient deceased with patient gown strings caught in side rail of bed.Per don patient was resident of the nursing home due to multiple cardiac and respiratory issues.Patient was oxygen dependent and needed assistance to get in and out of bed.Patient would not get out of bed without assistance due to weakness.Patient used a walker on a daily basis when out of bed.Patient was found sitting on floor; his back was leaning against his bed with his chin resting on his chest.The neck of the gown was caught around the raised edge of the siderail end cap.Gown strings were tied, ends of strings were not entangled on any part of the siderail or bed.Bed was in it's lowest position; head of bed elevated to an unknown degree, with both upper side rails in the up position.Patient call button was within reach, no bed alarm was on.Patient bed was not manufactured by medline.The age and overall condition of the bed and siderail is unknown.A root cause for this incident has not been determined.Due to the reported death and in an abundance of caution this medwatch is being filed.Device not returned.

Event Description

Patient found on floor with gown attached to bedrail and pronounced dead.

• Type of Device: GOWN, PATIENT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 6004595
• MDR Text Key: 56760201
• Report Number: 1417592-2016-00100
• Device Sequence Number: 1
• Product Code: FYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: MDTPG5RTSDEMZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 81 YR
• Patient Weight: 89