MAUDE Adverse Event Report: CARROLL HEALTHCARE CARROLL CS SERIES CS7 BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number IHCS7

Device Problem Device Fell (4014)

Patient Problem Disc Impingement (2655)

Event Type  Injury  

Manufacturer Narrative

When the event was initially reported, the results of the doctor's mri were requested but were not provided.No further details regarding the injury were available, and no medical treatment was reported; therefore, an mdr was not filed.An mdr is now being filed out of an abundance of caution due to the allegation that the bed incident caused/contributed to the doctor's herniated discs, which required surgical intervention.It has not been confirmed that the incident directly resulted in the doctor's injuries, but it also cannot be ruled out that the bed failure was a contributing factor.The doctor¿s medical records have been requested, relating the injury to the bed failure, but they have not yet been received.The sales representative who went to the facility after the event occurred advised that the doctor ran into the side of the bed as she was sitting down, and the bed dropped to the ground.It was discovered that the leg assembly had fallen out of the glide channel holding it in place.He stated that the facility administrator was already sitting on the other side of the bed when the incident occurred, but she did not report any injuries.He stated that their exact combined weight is unknown, but it is possible their combined weight could be over the bed's weight capacity of 500 pounds, and they should not have been on the bed together.He replaced the bed, and the subject bed was removed from the facility and disposed.Though the bed was no longer available for evaluation, a photograph of the bed was provided, which showed that the leg assembly had come out of the glide channel on the frame of the bed.Under normal operating conditions, this failure will not occur, which was confirmed in testing prior to product launch.However, if the bed frame/glide channel becomes deformed from product misuse (i.E.Overloading one side of the bed or obstructing the bed during operation), then the leg assembly becomes susceptible to migrating out of the channel.The cs series user manual (part number 1153410 rev q) warns, "never permit more than one individual on the bed at any time.Body weight should be evenly distributed over the surface of the bed." it also states, "to avoid serious injury or product damage, keep all moving parts, including the main frame, mattress deck, and all drive shafts, free of obstruction during operation of the product." in addition, the ihcs7 bed was manufactured in october 2007; therefore, it has exceeded its expected life of 10 years.Since the manufacture of this bed, an update was made to the design of the glide channel, which eliminates the potential for the leg assembly to migrate out of the channel in the event of product misuse.The ihcs7 bed was manufactured by carroll healthcare, an affiliate of invacare; however, carroll healthcare is no longer in business.The manufacture of these beds has transitioned to flextronics, but invacare continues to own the design.Therefore, the mdr is being filed under the invacare (b)(4) registration number.

Event Description

On (b)(6) 2018, a nursing home facility reported that a doctor sat on the ihcs7 bed, and the bed collapsed.The doctor allegedly experienced soreness in her neck/shoulder following the incident, resulting in an mri being performed.On (b)(6) 2018, a third-party administrator for worker's compensation benefits contacted invacare alleging that the doctor sustained herniated c5 and c6 discs from the incident, for which she received surgery on (b)(6) 2018.

• Brand Name: CARROLL CS SERIES CS7 BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CARROLL HEALTHCARE; one invacare way; elyria OH 44035
• Manufacturer (Section G): CARROLL HEALTHCARE; one invacare way; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 8240336
• MDR Text Key: 132820376
• Report Number: 1525712-2019-00002
• 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: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: IHCS7
• Device Catalogue Number: IHCS7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2007
• 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
• Patient Outcome(s): Required Intervention