MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO GOBED II; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number FL28EX

Device Problems Break (1069); Device Slipped (1584); Mechanical Jam (2983)

Patient Problem Pain (1994)

Event Date 03/11/2019

Event Type  malfunction  

Event Description

It was reported that while raising the bed, the footend of the bed unexpectedly dropped.A patient was in bed at the time and was said to have experienced pain from the event, and was administered an unknown analgesic.Upon evaluation by a stryker technician, it was found that while the nurse was trying to raise the bed, it became stuck on something which prevented the unit from raising, however the motors continued to run up until they became damaged.

Manufacturer Narrative

Upon reaching out to the user facility for further information regarding the alleged injury, the facility indicated that there had been no injury to the patient related to the event.

Event Description

It was reported that while raising the bed, the footend of the bed unexpectedly dropped.A patient was in bed at the time and was said to have experienced pain from the event, and was administered an unknown analgesic.Upon evaluation by a stryker technician, it was found that while the nurse was trying to raise the bed, it became stuck on something which prevented the unit from raising, however the motors continued to run up until they became damaged.

• Brand Name: GOBED II
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8510501
• MDR Text Key: 141803550
• Report Number: 0001831750-2019-00294
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327169386
• UDI-Public: 07613327169386
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FL28EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1