MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-03-26 for PARKER BATH AL27010-US manufactured by Arjo Hospital Equipment Ab.
[139806587]
(b)(4). The involved device was evaluated by the arjo technician. Upon the inspection it was found that an air jet cap was missing on the upper right on the back area. The customer facility representative was not able to determine how the air jet cap fell off. The customer covered the air jet outlet with tape and did not remove the device from usage. Other functions of the bath were working according to the manufacturer's specification. The involved bath was under the arjo service contract at the time of event. According to the received information the last preventive maintenance was carried out on 10/12/2018. The parker bath is subject to wear and tear, and some actions must be performed when specified to ensure that the product remains within its original manufacturing specification. To avoid malfunction resulting in injury, the user should make sure to conduct regular inspections and follow the recommended maintenance schedule provided within the parker instructions for use (ifu). Please note that according to instructions for use delivered with the device (04. Al. 01_7 dated on june 2012), user of the bath in question should follow the instructions from the booklet. In connection with a subject of this investigation, the ifu provides preventive maintenance requirements including those related to air jets. In section "care and preventive maintenance" the ifu the preventive maintenance schedule is available, which includes the obligation to visually check all exposed parts (such as air jets) on a weekly basis: "visually check all exposed parts, especially where personal contact is made by either the resident or caregiver. Make sure no cracks or sharp edges have developed that could cause the resident or user injury. " it should be underlined that requirements related to air jets are also provided in ifu section for qualified personnel and within the parker maintenance and repair manual (m&rm; 09. Al. 03_4en dated on november 2017). According to these documents, replacement of air jet caps after every 3 years of usage is recommended. Therefore all air jet caps should have been replaced at least one time within this product's usage period. Based on the collected information this requirement was probably not fulfilled. It should be taken into account that according to provided description of event the customer facility representative was not able to determine how the air jet cap fell off and the faulty part was also not kept for inspection. The review of reportable events with the involvement of the parker bath in last 5 years, revealed one similar incident, where a patient sustained an injury due to missing or fell off cap of the air jet. In summary, according to the gathered information, the air jet cap fell off, so the device was not up to the manufacturer's specification at the time of event. The bathtub was used for patient hygiene when the malfunction occurred and in that way it played a role in this event. This complaint was decided to be reported to the competent authority in abundance of caution as the injury occurred.
Patient Sequence No: 1, Text Type: N, H10
[139806588]
Arjo was notified about an event with the involvement of the parker bath. It was reported that the resident was taking a bath, when an air jet cap (ps1463) fell off and scratched the resident back. According to the received information first aid was administered and bandages were applied on the injured area. The customer covered the air jet outlet with tape and bathtub was used further by the customer despite that malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2019-00054 |
| MDR Report Key | 8451091 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-01-30 |
| Date Facility Aware | 2019-02-27 |
| Report Date | 2019-03-26 |
| Date Reported to FDA | 2019-03-26 |
| Date Reported to Mfgr | 2019-03-26 |
| Date Mfgr Received | 2019-02-27 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2019-03-26 |
| 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 | MS. KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer G1 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV, 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARKER BATH |
| Generic Name | BATH, HYDRO-MASSAGE |
| Product Code | ILJ |
| Date Received | 2019-03-26 |
| Model Number | AL27010-US |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV, 24121 SW 24121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-26 |