MAUDE Adverse Event Report: HILL-ROM MEXICO CAREASSIST, GENERIC; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P1170D

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

Directly after the incident occurred, the hospital biomed department examined the bed and found the bed to be functioning properly.A hill-rom service technician made an on-site visit.The serial number was not provided by the hospital and therefore a hill-rom service technician was unable to assess the bed¿s functions.As the account did not provide the serial number for this bed, hill-rom was unable to confirm when or if hill-rom performed any preventive maintenance on the bed.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the patient was found in her room standing at the foot end of the bed.The patient reported to nursing staff at the hospital that she had caught her foot in the side rail.As a result, the patient sustained a left ankle trimalleolar dislocated fracture that required surgical intervention.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: CAREASSIST, GENERIC
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 8345448
• MDR Text Key: 136342183
• Report Number: 3006697241-2019-00017
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: P1170D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/15/2019
• 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): Other
• Patient Age: 77 YR