MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ROTOPRONE; IKZ

Device Problems Cut In Material (2454); Patient-Device Incompatibility (2682); Difficult to Open or Close (2921)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).When reviewing reportable events for rotoprone device we were able to establish that there have been similar complaints in the past, which relates to buckle being unable to open.There is no trend observed for this failure mode however.The product involved in the incident is a rotoprone bed serial number: (b)(4).The device is part of the arjohuntleigh us rental fleet and has been rented to the customer (b)(6) rehabilitation center.Upon the conducted investigation we were able to confirm that this device passed the quality control on september 23, 2016, before being placed at the customer site.The customer alleged that the when the nursing staff was trying to place the bed surface in supine position per protocol, the bed 'whipped the patient as fast as it could all the way to the right side at a 90 degree angle'.They were able manually turned the bed to supine position.When the nurse was trying to unbuckle the patient, the chest buckle would not release.Since, the patient did not tolerate supine position, started to desaturate and continue to low 20s.A scalpel was used to cut the buckle to release the pressure on the patient.The saturation was regained.The patient was successfully transported to the icu bed.The device was returned to the service centre for evaluation.The buckle that was cut off was checked for defects.No defects were found, the buckle operated per manufacturers specifications.It was stated that, the patient who used the devices is 378 lbs and 5 ft tall.As per user manual #208662-ah rev.D section 'contraindication': patient conditions for which the application of kinetic therapy and the rotoprone therapy system are contradicted include: [.] patient weight above 350 lbs [.]'.If the patient is packed in too tightly, the button on the buckle does require more force to release.With a larger patient, one that is in excess of the recommended rotoprone weight limit of 350lbs, it is more likely for such situation to occur.Tightness of pack straps will vary according to each patient's needs.Straps need to be as tight as can be tolerated, as patient will shift into the prone packs and away from the patient surface when moved into prone position.Buckle is released by pressing the button inside the buckle.It is also worth noting that the buckles are designed to keep the patient weight from shifting when the patient is in the prone position.The alleged occurrence of the bed "whipping" to the right side at a 90 degree angle could not be duplicated during bed's evaluation.In summary, the rotoprone bed was used for patient treatment at the time of event occurrence and thus played a role in the incident.However after a comprehensive evaluation it was found that the bed was up to its specification.With all information gathered, it seems that the root cause of this event is related to the patient's size: the patient's weight did exceed the recommended rotoprone weight limit.The exceeded weight likely led to the situation in which bed whipped to the right side at a 90 degree and further inability to open the buckles.Although no injury was sustained as a result of this event it was decided to report it to the competent authorities based on the potential for serious injury ( inability to open the buckles in this particular event, led to low level of oxygen saturation, since the patient did not tolerate supine position).Given the circumstances and the fact that there is no trend observed for this failure mode arjohuntleigh does not propose any other action at this time.

Event Description

On september 29, 2016 arjohuntleigh was informed about the incident that took place on (b)(6) 2016 at (b)(6).It was reported that when trying to place the bed in supine position from prone, the rotoprone bed all of a sudden shifted to a 90 degree angle.The nurse was trying to troubleshooting the bed, however the screen remained in the rotation status.They then used manual rotation feature to place the bed in supine position, with success.It was decided to take the patient out of the bed and transferred to the normal icu bed.When attempting to unbuckle the patient, it was reported that the chest buckle would not release.Since, the patient did not tolerate supine position, started to desaturate and continue to low 20s.A scalpel was used to cut the buckle to release the pressure on the patient.The saturation was regained.The patient was successfully transported to the icu bed.

• Brand Name: ROTOPRONE
• Type of Device: IKZ
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2, P; PL 62-052, PL
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2, P; PL 62-052, PL
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 6062781
• MDR Text Key: 58600600
• Report Number: 3007420694-2016-00224
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/28/2016,09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2016
• Distributor Facility Aware Date: 09/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2016
• Date Manufacturer Received: 09/29/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 171