MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform was returned to zoll for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

It was reported during shift check that the autopulse stop compression and freezes itself.Customer also reported that the back enclosure of the platform is damaged.No patient involvement on this issue.

Manufacturer Narrative

The reported issue of the autopulse freezes itself and intermittently stop compression was not confirmed during the functional testing.The platform was tested using the manikin with lrtf (large resuscitation test fixture) with continuous compressions and passed with no issue or faults observed.Visual inspection was performed and found corrosion inside the internal metalized coating of the platform due to infiltration of blood, thus confirming the reported complaint of damaged back enclosure of the platform.The damaged top cover was replaced to remedy the issue.As part of routine service, the pdb (power distribution board) was replaced to current revision.Additionally, the clutch and brake area were also cleaned.Upon replacement of all parts, the platform was re-evaluated through functional testing and the platform passed all testing criteria.In reviewing this complaint file, it was noticed that the customer returned the li-ion battery s/n (b)(4) along with the platform for evaluation.However, there is no complaint reported against the li-ion battery.The battery was received with no led.When the battery was inserted into the mcc, the battery would not be fully charged and it showed 3 amber led.The battery exceeded its service life of three years and was manufactured on april 2013.The battery will be scrapped.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 6779129
• MDR Text Key: 82809662
• Report Number: 3010617000-2017-00648
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 09/05/2017
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2011
• 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