MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-16 for SARA COMBILIZER APA1000-WW manufactured by Arjohuntleigh Polska Sp. Z O.o..
[38857741]
This report is being filed under exemption (b)(4) by arjohuntleigh (b)(4) on behalf of the importer arjohuntleigh (b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[38857742]
The arjohuntleigh representative has been informed by the caregiver that she had injured her finger by the shoulder support when cpr was required for the patient. According to the caregiver, the shoulder support on the other side came pendulin and smashed her finger under the device support surface. The complaint was decided to be reportable based on the initial allegation related with an injury.
Patient Sequence No: 1, Text Type: D, B5
[41278806]
(b)(4). This appears to be a "malfunction" type of event not because there was an actual technical malfunction of the device (we found no evidence of it), but since the information received could be interpreted as the device not having performed as intended. When reviewing similar reportable events for devices from the same device range, we have been able to conclude that this complaint is considered to be a single, isolated event. The device involved in this incident is sara combilizer, model number apa1000-ww. Unfortunately, since the facility owns two sara combilizer devices they are not able to confirm which one exactly was involved in the incident and cannot provide a particular serial number. Furthermore, due to the missing serial number we were unable to check the device history nor establish the manufacturing date. All sara combilizer devices are manufactured in accordance to the current work instruction and 100% of them is checked during the final quality procedure to make sure that fully working device is being released on the market. Based on all information gathered to date we were able to confirm the alleged event - a caregiver has injured her 4th finger nail while starting the cpr procedure for the patient in the cardiac arrest. As stated by the person involved, she had to take down the shoulder support to make room for the doctors and she got injured while holding the side support on the other side to keep it from falling down hard. None of provided information indicates a device malfunction, that could have been a contributory factor for the issue occurrence. Also, the injury sustained did not require any medical intervention or treatment. The sara combilizer has two shoulder supports. The shoulder supports are adjustable for width and can also be folded during transfer. The instruction for use (ifu #04. Kc. 01_2 gb april 2014) clearly indicates how to operate the shoulder support in order to ensure safety usage. Both shoulder supports are secured by a spring lock; when the spring lock is pushed, the shoulder support on the caregiver side will fold down. However, in order to release the shoulder support on the opposite side of the operator, the same part needs to be pulled. In the ifu, there is a visible note added to be aware that the shoulder support will fold down quickly. In summary, upon the conducted investigation we have confirmed that none of available information indicates that device failed to meet its specification. The event occurred during a patient treatment given with help of arjohuntleigh device, therefore it did play a role in the incident. Based on the performed investigation, it seems like upon the event occurrence the caregiver operated the shoulder support not according to the manufacturer recommendation and that, with addition of the emergency situation specific circumstances, resulted in caregiver minor injury. The root cause for this event is related with caregiver operating procedure. The complaint was decided to be reportable to competent authorities based on a very limited information, initially being provided, which indicated a crushing type of injury. Nevertheless, upon this investigation and additional information provided we concluded that the event did not result in a serious injury and it is not likely to have such outcome should this was to reoccur. Therefore we no longer perceive this complaint as a reportable event. Given the circumstances it has been decided to provide a feedback to the customer and recheck if user manual is available the customer facility and if the staff is fully aware of its contains. We shall continue to monitor for any further events of this nature and do not propose any further action at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2016-00021 |
| MDR Report Key | 5437942 |
| Date Received | 2016-02-16 |
| Date of Report | 2016-01-27 |
| Date Facility Aware | 2016-01-27 |
| Report Date | 2016-02-16 |
| Date Reported to FDA | 2016-02-16 |
| Date Reported to Mfgr | 2016-02-16 |
| Date Mfgr Received | 2016-01-27 |
| Date Added to Maude | 2016-02-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE STE 308 |
| Manufacturer City | SAN ANTONIO TX 78219 |
| Manufacturer Country | US |
| Manufacturer Postal | 78219 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Street | UL. KS. PIOTRA WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARA COMBILIZER |
| Generic Name | INQ |
| Product Code | INQ |
| Date Received | 2016-02-16 |
| Model Number | APA1000-WW |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Address | UL. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-16 |