MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. ENTERPRISE 8000

Device Problems Failure to Charge (1085); Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that during the emergency situation, the caregiver was unable to adjust the bed into 'cpr position' with the use of the electrical cpr.There were no health consequences to the patient involved in the event.

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.Imp ref# (b)(4).

• Brand Name: ENTERPRISE 8000
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. piotra wawrzyniaka 2; komorniki; poznan 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. piotra wawrzyniaka 2; komorniki; poznan 6205 2; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4039952
• MDR Text Key: 20783900
• Report Number: 3007420694-2014-00069
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2014
• Distributor Facility Aware Date: 05/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2014
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• 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