MAUDE Adverse Event Report: STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS SPIRIT SELECT; BED, AC POWERED, ADJUSTABLE HOSPITAL

Model Number 5700

Device Problem No Audible Alarm (1019)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994); Unspecified Gastrointestinal Problem (4491)

Event Date 05/17/2021

Event Type  Injury  

Event Description

It was reported that the bed exit malfunctioned and a patient fell.The patient required surgery due to the fall.The reported bed exit malfunction could not be duplicated upon evaluation by stryker technical service.

Manufacturer Narrative

The b5 summary and section h codes have been updated to reflect the results of the completed investigation.

Event Description

It was reported that the bed exit malfunctioned and a patient fell.The patient sustained an intertrochanteric fracture, this fracture required an intramedullary fixation of the left intertrochanteric fracture to correct the issue.Furthermore, the patient underwent a colonoscopy due to a concern for decrease in hemoglobin.The patient was found to have diverticulosis.The reported bed exit malfunction could not be duplicated upon evaluation by stryker technical service.

• Brand Name: SPIRIT SELECT
• Type of Device: BED, AC POWERED, ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS; 1020 adelaide st. s.; N6E 1 R6; CA N6E 1R6
• MDR Report Key: 11970529
• MDR Text Key: 255367335
• Report Number: 0001831750-2021-00953
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327284546
• UDI-Public: 07613327284546
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

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?: Yes
• Device Operator: No Information
• Device Model Number: 5700
• Device Catalogue Number: 5700000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other