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

Model Number MODEL 100

Device Problem Positioning Failure (1158)

Patient Problem No Patient Involvement (2645)

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Event Description

It was reported that during a check performed by the customer, the autopulse platform's blue casing was observed to be cracked and the lifeband was unable to retract.There was no report of any patient involvement.No additional details were provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll (b)(4) on 10/23/2015.Investigation results as follows: a visual inspection of the returned autopulse platform was performed and found that the blue case was cracked, the short black cover was damaged and the battery latch lock was bent.Internal visual inspection of the unit showed no damages.Please note that the platform is a reusable device and therefore, these types of physical damages can occur due to normal wear and tear and/or physical abuse.A review of the archive was performed and no discrepancies were observed.The archive did not show any indications of lifeband being unable to retract, thus the reported complaint of the unit not pulling down the lifeband was not confirmed.The platform was functionally tested and the autopulse performed 30:2 and continuous compressions.Load cell characterization testing was performed and one of the load cell modules was not reading correctly.The load cell module not reading correctly is unrelated to the reported complaint.Based on the visual inspection, the parts replaced were the blue case, all associated parts, short black cover, battery latch lock and the defective load cell.Pdb board was also replaced as part of the service procedure.In summary, the customer's reported complaint of broken blue case was confirmed during visual evaluation.However, the reported complaint of the lifeband being unable to retract was not confirmed.After replacement of the parts identified during investigation, the platform passed all final functional testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5166024
• MDR Text Key: 28863102
• Report Number: 3010617000-2015-00571
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000079
• UDI-Public: 00849111000079
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• 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: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2008
• 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