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

Model Number MODEL 100

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.

Event Description

During shift check, the customer reported that two fully charged autopulse li-ion batteries (s/n (b)(4) and (b)(4) does not power on any autopulse platform (sn unknown).Sometimes the autopulse platform displayed strange characters.The autopulse platform does power on with other autopulse li-ion batteries without any issues.The two batteries were noted to have all 4 green led lights illuminated upon status check.No patient involvement.Please see the following related mfr report: mfr (b)(4) for the autopulse li-ion battery (sn (b)(4).Mfr (b)(4) for the autopulse li-ion battery (sn (b)(4).

Manufacturer Narrative

Correction h10: supplemental mdr was generated to retract the initial mdr that was submitted for the autopulse platform.The behaviour of the autopulse platform momentary (~100ms) powers on/off, flickers or strange characters of the lcd is entirely normal when a faulty battery is used.The autopulse platform powers on with other batterie and did not display strange characters, it is functioning as intended.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15143036
• MDR Text Key: 300225714
• Report Number: 3010617000-2022-01271
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

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: 8700-0730-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 08/05/2022
• Supplement Dates FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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