MAUDE Adverse Event Report: HILL-ROM DE MEXICO HILL-ROM 405 BED

Model Number 1440

Device Problems Collapse (1099); Unintended Head Motion (1284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2014

Event Type  malfunction  

Manufacturer Narrative

The technician investigated and found the right hand pivot is broken from the head deck.The technician stated the account could have possibly had a pt on the bed over the maximum weight threshold of the bed, but this cannot be confirmed.Per the hill-rom user manual: warning: do not use the product outside of the recommended pt height, weight, and width ranges.Pt injury or equipment damage could occur.Height[?]56" to 74" (142 cm to 188 cm).Width[?]36" (91 cm).Maximum pt weight[?]300 lb (136 kg).Safe working load[?]450 lb (204 kg) maximum, including pt weight, mattress, iv pumps, poles, bags, and such.The hill-rom representative called and spoke with the accounts biomedical and he stated this bed was in service for one day when the head section broke.There was a pt on the bed but there was no injury.The biomed feels the plastic joint was weak and broke when the pt was getting out of bed.He stated the pt was a large man but not overly obese.No further info is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant info is identified following completion of the investigation, the additional relevant info will be submitted in a supplemental report.

Event Description

Optima received a report from (b)(4).An account reported the head end of the bed collapses.The account reported there was a pt on the bed when the head section collapsed.The bed was taken out of service and located in storage at the facility when the issue was reported.There was no pt/user injury reported.

• Brand Name: HILL-ROM 405 BED
• Manufacturer (Section D): HILL-ROM DE MEXICO; s de rl de cv; apodaca ; MX
• Manufacturer Contact: dustin chen ; no. 42-1, fuyuan; guanyin hsiang taoyuan 328 ; TW 328 ; 0030004906
• MDR Report Key: 4824471
• MDR Text Key: 22538082
• Report Number: 3003463213-2015-00002
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1